Clinical Research Directory

RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this study will be used to guide development and refinement of new software features that may be implemented in future commercial software releases.

The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans

Cardiovascular disease (CVD) is a major and persistent health disparity for African Americans. Linking GAINS is a randomized pilot and feasibility study designed to evaluate whether receiving genetic risk information early in a community-based CVD risk reduction intervention improves engagement and health behavior change. Sixty African American adults from the Baton Rouge metropolitan area will be recruited and randomized to a Genetically Unblinded (GU) group or a Genetically Blinded (GB) group. All participants will complete a 14-session behavioral intervention delivered over approximately 16 weeks, including culturally responsive education, nutrition and cooking sessions, physical activity training, group support, and community-based health resources. The GU group will receive genetic results and genetic counseling early in the intervention, while the GB group will receive genetic results and counseling after the behavioral intervention and end-of-study assessment. The primary endpoint is intervention engagement measured by attendance. Secondary outcomes include physical activity, dietary intake, body mass index, blood pressure, genomic orientation/knowledge, and perceived racism. Exploratory/moderator analyses will examine whether social determinants of health, including income, food insecurity, health literacy, occupational prestige, and experiences of racism, influence intervention engagement and behavior change.

Minimally Invasive Hemodynamic Monitoring in Cardiac Ablation

This prospective observational clinical study aims to evaluate the clinical utility of Pressure Recording Analytical Method (PRAM)-based minimally invasive hemodynamic monitoring in patients undergoing cardiac ablation procedures. The study will be conducted in the cardiac catheterization laboratory of Istanbul University-Cerrahpaşa Cardiology Institute and will include 27 adult patients scheduled for catheter ablation. Written informed consent will be obtained from all participants, and the study will adhere to the principles of the Declaration of Helsinki.

Agilis RF TSP Early Feasibility Study

This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.

FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study

The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation. The study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm. The main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.

Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients

The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. Specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. The work consists of three broad categories: A) role of atrial cardiomyopathy in atrial fibrillation; B) genetic defects predisposing to atrial fibrillation; and C) the role of inflammation in atrial fibrillation.