Clinical Research Directory

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

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

The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

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.

The ENCIRCLE Trial

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation

DragonFly EU Pivotal Study

To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.

PARTNER 3 Trial - Mitral Valve in Valve

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice

Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making. South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.

Long Term Follow Up for CTSN Mitral Valve Repair Studies

This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

The purpose of this study is to evaluate the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients in a real-world setting

A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk

This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.

European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.

Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)

Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up). It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring. A number of echocardiographic and MRI parameters may have been associated with a poorer prognosis. A cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients. The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.

To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical Treatment

To confirm the effectiveness and safety of the transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial)

The PACO trial is a randomized clinical trial conducted in Heart Centers of Kuopio and Turku university hospitals. The coronary artery disease, aortic valve stenosis and mitral valve insufficiency patients preparing for elective coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or mitral valve repair (MVR) will be randomized to either intervention or control group. The specific operation groups (CABG, AVR and MVR) will be analyzed separately. The 7-day baseline measurements of sedentary behaviour (SB), physical activity (PA) and sleep will be conducted to the patients by using the RM42 accelerometer during the pre-operative month. After the cardiac procedure is completed and the patient is moved to post-operative ward, the control group patients will begin the standard post-operative rehabilitation program of the participating hospitals (activity guidance given by a physiotherapist). Patients in the intervention groups will follow the identical program but after discharge they will also receive personalized activity guidance through the combination of ExSed smart phone application, Suunto MoveSense accelerometer and cloud system during the first 90 days of post-operative rehabilitation. Weekly evolving daily goals to replace SB with PA (daily goals for steps, moderate PA, light PA and standing, and sitting time limit) will be designed for each patient of the intervention groups. A new daily step goal will be delivered from the cloud system to the patient's smart phone in the beginning of each week of the intervention. The daily step goal of the first intervention week is based on patient's walking distance assessed by a physiotherapist in post-operative ward. The following goals will be automatically evolved in the basis of patient's personal average step count of the previous week. The MoveSense accelerometer will measure accumulated levels of SB, PA and sleep, and transmit the data to user's ExSed application with Bluetooth. With information about accumulated levels of SB and PA, the application is able to guide the patient to accomplish the predefined activity goal. The guidance and motivation will be offered with pop-up notifications and histograms (columns are fulfilled according to patient's accumulated daily activity). The researches retain a remote access to the activity data of patients in the cloud system. The ExSed application will be connected to the cloud system with internet connection. In addition, the patients of the intervention groups will receive short video files (lasting from 1 to 3 minutes) containing exercise guidance from a physiotherapist specialized to cardiac operation patients. These videos are available on the ExSed application during the intervention. The physiotherapist will also contact each patient (by mobile phone) with structured contact form from 1 to 4 times in a month to make sure that the intervention is proceeding as designed.