Clinical Research Directory

EFS of the DUO System for Tricuspid Regurgitation

The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).

Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation

The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.

Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

The CLASP III TR CED Study

This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.

TTVR Early Feasibility Study

The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

TTVR STRONG Under Coverage With Evidence Development (CED) Study

This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.

Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation

Tricuspid regurgitation (TR) is an increasingly recognized valvular heart disease associated with high morbidity and mortality. With the availability of various novel transcatheter tricuspid interventions, it is no longer considered a "forgotten valve." Heart failure with preserved ejection fraction (HFpEF) is a prevalent condition also characterized by high morbidity and mortality. The prevalence of moderate to severe TR in the general population is 3% to 6%; however, in patients with heart failure (with reduced or preserved ejection fraction \[EF\]), the prevalence is 10% to 29%, rising to up to 39% in patients with HFpEF and atrial fibrillation (AF). The EuroTR registry, an international registry including patients who underwent percutaneous treatment for severe TR, reported that 72% of patients had a left ventricular ejection fraction (LVEF) ≥50%. In a subgroup of patients with right heart catheterization data, 68% had a pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg, indicating that many of these patients may have HFpEF. Patients with significant TR have also been shown to experience irreversible liver derangement and cirrhosis. Non-invasive evaluation of liver stiffness (LS), measured by transient elastography, has recently received increased attention in patients with heart failure and has been shown to closely correlate with right-sided filling pressures. LS has been used to predict adverse outcomes in patients undergoing transcatheter aortic valve (TA) surgery with concomitant left-sided valve surgery. On the other hand, the Remote Dielectric Sensing System (ReDS; Sensible Medical Innovations, Israel) is a device that measures lung fluid non-invasively and provides an objective and reproducible index of volume status. It is an FDAapproved device for heart failure patients. ReDS measurements are presented as the percentage of fluid relative to lung volume, with normal values ranging between 20% to 35%. Studies have demonstrated excellent correlations between the ReDS index and computed tomography (CT)-measured lung water and invasively determined hemodynamics. Additionally, it has been shown to predict heart failure rehospitalization in patients with acute heart failure. Given the emergence of novel transcatheter tricuspid interventions and the established link between TR, HFpEF, and markers such as liver stiffness and lung fluid index (measured by ReDS), this study will examine the intricate interplay between these conditions and their shared pathophysiology. By analyzing left and right heart function, risk factors, and treatment outcomes, the research aims to phenotype TR using non-invasive assessment tools to predict clinical outcomes and improve treatment strategies for patients with different types of TR. Our findings will contribute to developing more effective and personalized treatment plans for patients with TR.

Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

Tricuspid regurgitation (TR) is a common disease, and the tricuspid valve (TV) is no longer a "forgotten valve". Open heart surgery for isolated TR is uncommonly performed due to high operative risk (8-10% mortality). However, TR is associated with increased morbidity and mortality. There exists an unmet clinical need for less invasive intervention to treat TR. Transcatheter edge to edge repair (TEER) is a technique that is shown to be safe and effective in TR reduction and is associated with significant symptom improvement. However, a significant portion of TV anatomy are not suitable to be treated with TEER (e.g. coaptation gap \>10mm). A wide variety of technologies has been developed in recent years. Transcatheter tricuspid valve replacement (TTVR) is one of the more promising option for tricuspid regurgitation (TR) patients at high risk for surgery. A previous study reported that transcatheter tricuspid devices, which were employed with the radial force between the device and tricuspid annulus, were radial force-dependent. However, this radial force for valve fixation may cause complications, such as conduction block and right coronary artery impingement. The LuX-Valve (Jenscare Biotechnology) is a radial force-independent orthotopic TTVR device. The feasibility and efficacy of this device have been reported by several studies. However, this valve was implanted through right atrial access, where a small incision of the right chest and right atrium is needed. The LuX-Valve Plus valve replacement system is the second-generation version of the LuX-Valve and can be implanted through the jugular vein. The first-in-human implantation was recently performed. The study aims to assess the feasibility, safety and efficacy outcome of the Lux Valve Plus system in a cohort of otherwise no surgical option patients with severe symptomatic tricuspid regurgitation despite optimal medical therapy.

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device

The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs). The main objective is to compare left bundle branch area pacing (LBBaP) and leadless pacemakers against conventional pacemakers in terms of TR exacerbation. Participants with these devices will have their retrospective and prospective clinical data analyzed and will undergo 3D transthoracic echocardiography to identify the exact mechanical causes of TR.

A First in Human Study for the Versa Device for Tricuspid Regurgitation

This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.

TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.

Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function. Newer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear. The investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.

Laplace Early Feasibility Study - Canada

The objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Edwards CLASP TR EFS

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation

The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).

Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation

Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk. Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat. In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures. This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve. The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up. The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life. The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.

Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease

This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System

This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.