Clinical Research Directory

A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.

Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.

Echocardiography in Nursing Home

The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.

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.

Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery

Postoperative delirium is a frequent complication after cardiac surgery. This prospective observational study will evaluate whether cerebral blood flow velocity measured by transcranial Doppler before and during elective heart valve surgery is associated with delirium during the first five postoperative days. Bispectral index, near-infrared spectroscopy, and arterial blood gas data will also be recorded. Delirium will be assessed daily by an independent evaluator who is blinded to the intraoperative measurements and artificial intelligence predictions, using CAM-ICU for mechanically ventilated patients or the Turkish 3D-CAM for patients on the ward. The study will also compare zero-shot delirium risk predictions from five general-purpose large language models (Claude, GPT, Gemini, Grok, and Kimi) with the blinded clinical assessments. The models will not be trained on data from the study cohort.

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).

China Elderly Valve Disease Study III (China-DVD3 Study)

This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways.

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk. In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Paired-Ring Mitral Annuloplasty Ring Sizing Device

The purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.

MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

AI Assisted Screening for VHD Using Routine Chest CT Scans

This is a prospective, multicenter study designed to validate a deep learning model for screening valvular heart diseases using routine, non-contrast chest computed tomography (CT) scans. The primary objective is to evaluate the model's diagnostic performance, with the sensitivity serving as the primary efficacy endpoint. Secondary endpoints will include other performance metrics such as area under the receiver operating characteristic curve (AUC), specificity, and accuracy, etc.

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Multimodal mAgnetic Resonance imaGIng in Cardiovascular Disease

This single-center, prospective, observational cohort study aims to evaluate the clinical application value of multi-modal cardiovascular magnetic resonance (CMR) imaging in patients with cardiovascular diseases (CVD). While traditional imaging methods have limitations in fully evaluating myocardial tissue characteristics, multi-modal CMR offers a comprehensive, non-invasive "one-stop" assessment. It can simultaneously evaluate heart structure, function, tissue features (such as fibrosis and edema), and hemodynamics. The study plans to enroll patients with suspected or confirmed CVD. Participants will undergo a comprehensive multi-modal CMR scan (including Cine, T1/T2 mapping, Late Gadolinium Enhancement, and 4D flow sequences) as part of their evaluation. In addition to clinical evaluation, the study will explore sequence optimization (e.g., comparing pre-contrast vs. post-contrast Cine, and 3-slice vs. 9-slice T1 mapping) and evaluate deep learning-based virtual native enhancement (VNE) models trained under different sequence protocols. By tracking clinical outcomes, the study seeks to establish a standardized imaging assessment system to improve the early detection, accurate diagnosis, risk stratification, and prognostic prediction for various types of cardiovascular diseases.

The TRICURE EFS Study

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts were receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial would provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort. Subjects would be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).

TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)

TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical tricuspid heart valve, Model 11300T.

The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality

Cardiopulmonary Rehabilitation In Heart Valve Surgery

The aim of this study was to investigate the effects of postoperative early mobilization and Bottle-P.E.P. application on respiratory parameters and functional capacity in patients undergoing heart valve surgery.

2019-06 TRISCEND Study

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).

Effective Myocardial Protection Time of Del Nido Cardioplegia in Adult Cardiac Surgery

This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC). Without altering routine care, time-stamped high-sensitivity cardiac troponin (hs-cTn) measurements will be obtained at predefined intraoperative and early postoperative intervals to identify the inflection ("change-point") at which biochemical evidence of ischemic injury begins to rise. Eighty adults undergoing elective valve and/or thoracic aortic procedures with Del Nido cardioplegia will be enrolled. The primary endpoint is the intraoperative hs-cTn change-point time referenced to ACC. Secondary endpoints include associations between change-point and ACC duration, the presence/timing of any re-dose, and early clinical outcomes (e.g., low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, 30-day MACE and mortality). All cardioplegia choices (dose, route, temperature, re-dose decisions) remain per standard practice; no experimental therapy is administered. Risks are minimal and limited to small-volume blood sampling coordinated with routine draws.

TRISCEND II Pivotal Trial

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system