Clinical Research Directory

Aveir AR Coverage With Evidence Development (CED) Study

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients.

Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV.

Cardiovascular Risk in Patients With Primary Hyperparathyroidism

Patients with primary hyperparathyroidism versus healthy controls assessed for their cardiovascular risk and overt CVD

Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation

Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence. This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA. Participants will: * Be randomly assigned to either the CPAP group or the usual care group. * If in the CPAP group, use a CPAP device for 12 months. * Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months after randomization. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after randomization.

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

HELP-A is a prospective, randomized, open-label, multicenter comparative-effectiveness trial comparing two ambulatory electrocardiographic monitoring strategies in adults with palpitations or dizziness and a nondiagnostic 12-lead ECG. A total of 588 participants are randomized 1:1 to 30-day intermittent handheld 6-lead ECG monitoring (Hativ) or up to 7 days of continuous single-lead patch ECG monitoring (Memo Patch). The primary endpoint is clinically informative symptom-rhythm correlation established with the initially assigned device by the 1-month follow-up visit. Participants without a symptom-rhythm correlation who remain symptomatic may undergo optional sequential monitoring with the alternative device after primary endpoint ascertainment. Clinical outcomes, arrhythmia-directed interventions, healthcare resource utilization, costs, and adverse events are assessed through 3 months.

Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor

Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA). Primary Objective: To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score \> 3, by comparing to the attended in-lab PSG, the gold standard. Secondary Objectives: To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG; To assess the accuracy of the BR arrhythmia detection algorithm; To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies; To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance; To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis; To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).

Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery

The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos. The study is sponsored by Medicine Campus Davos AG and the Kühne Foundation, with an estimated start date in July 2025 and planned completion by December 2034, with the possibility of extension. The principal investigator of the study is PD Dr. David Niederseer from Hochgebirgsklinik Davos, who also represents the study. The research team includes co-investigators such as Prof. Dr. Stefan Blankenberg and Prof. Dr. Andreas Ziegler from Cardio-CARE, Medicine Campus Davos, as well as Dr. Jan Vontobel from Hochgebirgsklinik Davos. The study will enroll patients referred to Hochgebirgsklinik Davos for cardiac rehabilitation who provide informed consent. Cardiac rehabilitation is an evidence-based therapy for patients with heart disease, including those who have undergone cardiac procedures or surgeries. The primary objectives are to evaluate baseline patient characteristics, rehabilitation strategies, predictors of recovery, and clinical outcomes during and after rehabilitation. To support this, a detailed database and biobank will be established to allow for comprehensive phenotyping, extensive clinical assessments, and long-term follow-up. RECOVER seeks to gain translational insights into how patient-specific factors - such as genetics, plasma, digital and clinical biomarkers, and comorbidities - influence long-term clinical outcomes. The goal is to identify modifiable risk factors to optimize individualized therapeutic approaches in cardiac rehabilitation.

Quality of Life Before and After Transcatheter Ablation in Children With Arrythmias

The goal of this clinical trial is to evaluate the improvement in the quality of life after the transcatheter ablation in children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation (according to PACES recommendations). The main question is how to evaluate an improvement in the quality of life in these children, according to different questionnaires? Participants will answer some questionnaires to get a global evaluation of the quality of life: * Peds QL 4.0 * Peds QL 4.0 by proxy, which will be completed by the parents * Ricci and Gagnon questionnaire * Child Depression Index * State and Trait Anxiety Inventory

Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy

The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are: I. Does patients with arrhythmia-induced cardiomyopathy have a greater proportion of genetic mutations compared with other types of cardiomyopathy or general population? II. Have the genetics any prognostic impact in patients with arrhythmia-induced cardiomyopathy?

RHYthm and Myocardial Function Relationship Evaluation in Heart Diseases

Arrhythmias are widespread among the global population. Although they can occur in healthy hearts, they are often the manifestation of a hereditary or acquired heart muscle disease, and may be the cause or, more often than not, the consequence. In recent decades, with advances in medical knowledge and technology, non-pharmacological therapies for arrhythmias have become increasingly popular. These fall into two broad categories: therapies aimed at electrostimulation and those aimed at ablation of arrhythmias. The selection of patients eligible for these procedures is essential for the effectiveness of the therapy, the reduction of complications and the optimisation of resources. Not all patients, even those selected according to guidelines, respond equally to the chosen therapy. Other patients, due to their clinical/ECG characteristics, do not have clear indications and remain in a borderline area where the class of evidence and/or recommendation of the guidelines is less stringent. Still others develop recurrences or complications during follow-up that require further intervention. In this context, it is essential in the study of these patients not only to use standard instrumental examinations, such as echocardiograms, Holter ECGs and stress tests (simple and cardiopulmonary), but also and above all to use advanced imaging methods (STE, 3D echo, MRI, CT, PET-CT) and remote monitoring tools that integrate diagnostic algorithms managed by artificial intelligence. In light of these considerations, our project consists of conducting an observational study that includes all patients with arrhythmias who are candidates for electrostimulation and/or ablation procedures at the Arrhythmology Unit and/or followed up at the Arrhythmology Clinic of our Polyclinic, in order to assess the clinical and/or imaging characteristics associated with a worse prognosis in this population, in terms of response to therapy and development of complications. Our main aim is to identify, within the above-mentioned population, the subgroups of responder patients versus non-responder patients, i.e. those with a worse prognosis , who deserve greater attention and more frequent follow-up.

The Impact of Video-based Cardiac Rehabilitation Education in Patients With CIEDs

Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases. International and clinical guidelines currently recommend exercise training and rehabilitation for heart failure patients, which can effectively improve mortality and prognosis. However, few of these recommendations have specific recommendations for patients with cardiac implantable electronic devices. Currently the recommendations of cardiac rehabilitation include patients with coronary heart disease (acute coronary heart disease, any coronary revascularization, stable coronary disease or unstable angina), patients with heart failure, after cardiac surgery, and patients with high cardiovascular risk. Many of these patients may be implanted with cardiac implantable electronic devices. In 2011, 938 pacemakers, 140 cardiac resynchronization therapy and 149 implantable cardioverter defibrillators were implanted per million inhabitants in Europe. Therefore, among the groups with cardiac implantable electronic devices, cardiac rehabilitation plays a certain role. The purpose of this study is to evaluate whether video-based cardiac rehabilitation health education for patients with cardiac implantable electronic devices has significantly improved physical activity. This study is designed as a prospective, single center, double-blind, randomized controlled trial. Divided into an experimental group and a control group at a ratio of 1:1. The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention, and the control group will receive only health education. We aim to recruit 45 participants per group with a total of 90 participants.

Computed Tomography of Pulse-Field Ablation

Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) reduces left atrial (LA) volume post-ablation, a phenomenon termed reverse atrial remodeling, indicative of successful reversal of atrial cardiomyopathy progression. In contrast, pulse field ablation (PFA), a novel non-thermal technology, offers a promising efficacy and safety profile without inducing persistent atrial fibrosis. While RFCA-associated reverse atrial remodeling is well-documented, it remains uncertain whether PFA, operating on a non-thermal paradigm, also promotes this remodeling, which would enhance its physiological relevance in AF treatment. Additionally, RFCA studies show that LA wall thickness at the pulmonary vein (PV) antrum can predict PV reconnection and arrhythmia recurrence, but whether PFA affects LA thinning or enables similar predictions from post-treatment computed tomography (CT) scans is unknown. Moreover, epicardial adipose tissue (EAT), strongly linked to LA abnormalities and AF recurrence, can be quantified via CT, yet the impact of PFA on LA EAT remains unexplored. Finally, PFA's versatility, particularly in isolating the LA posterior wall (LAPW) in non-paroxysmal AF, raises questions about its effect on posterior wall thinning or EAT changes, factors associated with post-ablation recurrence

Case-Based Collaborative Learning for Arrhythmia Recognition in Novice Intensive Care Nurses

This randomized controlled trial evaluates the effectiveness of case-based collaborative learning (CBCL) in improving arrhythmia recognition and patient safety attitudes among novice intensive care nurses. Newly graduated nurses with less than one year of professional nursing experience working in coronary or cardiovascular surgery intensive care units are randomly assigned to an intervention or control group. Both groups participate in the institution's routine orientation process for newly employed intensive care nurses. In addition, the intervention group receives a structured CBCL-based arrhythmia education program delivered in two 120-minute sessions over two consecutive weeks. The program uses clinical case scenarios, ECG tracings, individual assessment, small-group collaborative discussion, shared clinical decision-making, and structured feedback. The control group receives no additional study-specific arrhythmia education during the study period. The primary outcome is arrhythmia recognition and awareness, and the secondary outcome is patient safety attitudes. Outcomes are assessed at baseline and at the three-month follow-up in both groups. An additional immediate post-intervention assessment is conducted in the intervention group to examine short-term changes following the educational program.

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are: 1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease? 2. How does the use of this algorithm affect clinical decision-making and patient outcomes? Researchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not. Participants (healthcare providers) will: Be randomized into two groups: one that receives AI-based ECG results and one that does not. In the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG. Decide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.

7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations

"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with palpitations. Participants who require 24-hour Holter monitoring because of symptoms such as palpitations or dizziness will simultaneously wear a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor will be removed after 24 hours, while the MEMO Patch will continue monitoring for a total of 7 days. ECG recordings will be evaluated by cardiologists after technical quality assessment. The study will assess arrhythmia detection, device-related skin adverse events, and participant usability and satisfaction."

Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation

The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.

HeartBeam ECG Registry

The HeartBeam ECG Registry will collect ECG recordings acquired with the HeartBeam System with relevant clinical information in clinical settings.

Prospective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting

Suspected acute or subacute cardiovascular diseases-including chest pain, dyspnea, and palpitations-are among the most common reasons for unscheduled emergency department visits and pre-hospital referrals. Despite this high clinical burden, the diagnostic yield is often limited, with a frequent mismatch between initial clinical suspicion and final diagnosis, contributing to substantial healthcare utilization and hospitalization rates. Current evidence is largely focused on specific conditions such as acute coronary syndromes, heart failure, arrhythmias, or pulmonary embolism, and rarely integrates the full spectrum of clinical, biological, and imaging data obtained during initial evaluation. To address this gap, we will establish a prospective cohort of all consecutive patients referred to the ambulatory day-hospital cardiology unit at Lariboisière University Hospital. This unit acts as a specialized downstream referral structure within the emergency care pathway, receiving patients after triage by emergency physicians, pre-hospital regulation services (SAMU), mobile intensive care units (SMUR), or emergency departments. Although it does not capture all suspected cardiovascular emergencies, it represents a selected real-world population deemed to require specialized acute cardiology assessment. The primary objective is to assess the frequency of cardiac conditions diagnosed in this cohort. Secondary objectives include characterization of patient profiles and diagnostic pathways; evaluation of the diagnostic and prognostic performance of clinical, biological, imaging, and multimodal parameters using final Heart Team diagnosis as reference; analysis of prior health history and healthcare utilization; and assessment of the medico-economic burden of suspected acute cardiovascular disease. The study will further support the development of a dedicated biobank and the validation of next-generation biomarkers, including AI-driven and voice-based markers, as well as decision-support algorithms for binary classification of cardiac involvement. Through integration of multimodal data and linkage with national health records, this approach aims to improve diagnostic accuracy, risk stratification, and understanding of the healthcare impact of acute cardiovascular presentations in a real-world setting.

First-time Ablation of Atrial Fibrillation Registry

Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success. The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers.

AI-powered ECG Analysis for Deadly Arrhythmias and ICI Myocarditis

ELDORA is a non-interventional observational data-science study aiming to develop and validate clinical-grade artificial intelligence tools applied to electrocardiogram (ECG) data. The project will standardize heterogeneous ECGs, create the ECGInsight harmonized database, and train interpretable models for life-threatening arrhythmia risk prediction, especially Torsades-de-Pointes/long QT syndrome and immune checkpoint inhibitor (ICI)-induced myocarditis. The project uses existing and ongoing national and international ECG cohorts with de-identified clinical metadata; AI outputs are intended for research/model development and are not used to drive patient care during the study.

DiamondTemp Global Registry

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Outcome of Ablation of Tachyarrhythmias in Patients With Congenital Heart Diseases

Our observational study aim to to evaluate the incidence of Tachyarrhythmia in patients with congenital heart diseases (corrected/non corrected) and the effectiveness of catheter ablation.RF catheter ablation was performed to all patients and follow up for recurrence was done for one year.

Pediatric Adhesion and New Dermal Approach Study

The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.