Clinical Trials for Heart Valve Diseases

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Heart Valve Diseases from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 30
• Active, not recruiting: 7
• Completed: 3
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT02432092 — Pediatric Cardiomyopathy Mutation Analysis

The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

NCT03628313 — Valvular Aortic Stenosis Prognosis Study

Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.

The main objective of this work is to…

NCT04442100 — 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

NCT03242642 — Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

NCT04097145 — 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

NCT04433065 — 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.

NCT04258488 — Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement

This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.

NCT05061004 — Cephea Early Feasibility Study

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

NCT05172960 — ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

NCT05493657 — Aspirin vs Clopidogrel After TAVR

Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing TAVR for severe aortic stenosis. This study is designed as a prospective, multicenter, open label, randomized control…

NCT05496998 — Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved t…

NCT05851209 — Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study

Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.

NCT06279793 — Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients

The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.

A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.

NCT05646381 — A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

NCT06557798 — REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a ’tissue’ valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue deg…

NCT05672836 — ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

The goal of this trial is to to determine whether use of a novel SGLT2 inhibitor, Enavogliflozin 0.3 mg once daily is superior to placebo, when added to standard-of-care, in reducing the composite of major cardiovascular events and Heart Failure events (hospitalization for Heart Failure or urgent Heart Failure visit) among patients who underwent transcatheter aortic valve replacement for severe…

NCT06241430 — The CardioClip Study

The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medication…

NCT06859255 — In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation

The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.

The study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardia…

NCT06871774 — Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

NCT06608823 — ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)

NCT07001800 — Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

NCT07194265 — A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

Prospective, randomized, controlled, multicenter, international study.

Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the ‘All Comers Randomized Cohort’. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commerc…

NCT07243184 — The Feasibility Study of Polymer Artificial Heart Valve for the Treatment the Mitral Valve Disease.

The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.

NCT07343674 — PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI

The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.

The main questions it aims to answer are:

• Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency?
• What are th…

NCT07541833 — Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan

NCT07691307 — A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement

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

NCT07276711 — CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.

NCT07586995 — A Post-Market Assessment of the Safety and Performance of the TriClip™ System

The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.

NCT07662317 — Construction of a Prospective Cohort Database for the Perioperative Period of Cardiac Surgery

Cardiovascular disease (CVD) is the leading cause of global morbidity and mortality, with its prevalence increasing significantly from 1990 to 2019. Establishing a comprehensive cardiac surgery database is crucial for exploring perioperative prognostic factors and improving clinical outcomes.

This muti-center, prospective observational study aims to construct a prospective cohort database for …

NCT07450911 — The ReValve Clinical Trial an Evaluation of the ReValve Palmetto Valve for the Replacement of the Native Mitral Valve

An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

Active, Not Recruiting

NCT01586910 — Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and ef…

NCT03655223 — Early Check: Expanded Screening in Newborns

Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health condi…

NCT03706833 — Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

NCT05182307 — DurAVR™ THV System: EMBARK Study

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

NCT05051033 — Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for T…

NCT05712161 — Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

NCT07023341 — A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Researchers are looking for a better way to treat Japanese people who have symptomatic obstructive hypertrophic cardiomyopathy (symptomatic oHCM).

Obstructive hypertrophic cardiomyopathy (oHCM) is a type of heart disease where the heart muscles become thicker than normal due to over contraction. This thickening makes it harder than normal due to over contraction. This thickening makes it harde…

Not Yet Recruiting

NCT07631156 — STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure

This is a multicenter, randomized, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopat…

NCT07671820 — Anchord Mitral Chordal Repair System - FIH

The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question[s] it aims to answer are to assess the safety of procedure, the reduction in mitral…

NCT07668739 — Efficacy of Verciguat in TR and RV Failure

The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function. It will also examine the effects of the drug on tricuspid regurgitation (TR) and overall clinical outcomes.

The main questions it aims to answer are:

Does vericiguat improve right ventricular (RV) function…

NCT07549490 — Human Experimental Models of Pain (HEMP)

This pilot study will test an innovative way to establish how pain medicines provide analgesia in healthy adults. The study uses a group of short, controlled pain tests to look at different types of pain responses in the body. The main goal is to find out if this testing approach can show the pain-relieving effects of 2 medicines, pregabalin and naproxen versus placebo, and show how they provid…

NCT07684313 — 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.

NCT07689279 — Selection of Transcatheter Heart vaLve With Intermediate Sizing in Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Replacement

Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations. Two types of transcatheter heart valves, balloon-expandable and self-expanding, exhibit distinct hemodynamic and structural characteristics that influence procedural strategy and long-term …

NCT07687485 — 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).

NCT07690748 — Remote Monitoring for Patients With Aortic Stenosis

Remote-AS aims to develop a remote digital monitoring cohort of people with AS and use these data to establish a digital twin intervention to personalise risks and benefits, and optimise the time of surgical or transcatheter aortic valve replacement (AVR) referral. Our digital solution will also seek modelling for optimal care for patients to whom AVR is indicated who choose not to undergo the …

NCT07675668 — Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy

The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development. The main questions it aims to answer are:

1. Which dose is safe and tolerant of Aom0304 in participants with HCM?
2. Which dose is effective of 12 weeks of Aom0304 treatment in participant…

Completed Trials

NCT03877731 — Mitral Valve in Hypertrophic Cardiomyopathy

The purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients

NCT02706639 — Williams Syndrome (WS) and Supravalvar Aortic Stenosis (SVAS) DNA and Tissue Bank

Williams syndrome is a rare genetic disorder occurring in 1:8000-12,000 individuals. It is caused by the deletion of 25-27 coding genes, including elastin (ELN) on the 7th human chromosome. Haploinsufficiency for these genes leads to the features of the condition, including:

• Distinctive facial features;
• Characteristic vascular problems including hypertension, focal vascular stenosis, (when…

NCT02692846 — WS-SAVE Study (Williams Syndrome Skin and Vessel Elasticity Study)

Background:

Williams Syndrome (WS) is a genetic disorder. People with WS have less of a protein that allows parts of the body to stretch than other individuals. Researchers are interested in the stretchiness of the skin of people with WS and how it may relate to cardiovascular problems some people with WS develop. They are also interested in identifying exposures such as medications that may c…

Other (Terminated)

NCT03813524 — Cardiovalve Transfemoral Mitral Valve System

This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.