Clinical trials: Valve Heart Disease
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
Aortic Valve Disease
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
- Trial name
- NCT00619151
- Testing
- Top Hat, Regent
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Heart Failure, Mitral Valve Insufficiency
The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that…
- Conditions
- Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies
- Trial name
- NCT02806570
- Testing
- Mitral valve repair
- Where
- 16 sites in United States
- Volunteers
- 35 people
- Sponsor
- Ancora Heart, Inc.
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Tricuspid Valve Regurgitation
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- TRIBUTE (NCT05767645)
- Testing
- Mistral Procedure
- Where
- Israel
- Volunteers
- 75 people
- Sponsor
- Mitralix
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475267
- Testing
- Trifecta aortic heart valve
- Where
- 5 sites in Canada
- Volunteers
- 203 people
- Sponsor
- Abbott Medical Devices
Obstructive Hypertrophic Cardiomyopathy
Real-world Patient Reported Outcomes Among Patients Treated With Camzyos
This real-world study will assess changes in health status among participants with symptomatic obstructive hypertrophic cardiomyopathy who are treated with mavacamten in the real world.
- Trial name
- COMPASS-HCM (NCT06551129)
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
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…
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- Trial name
- CLASP II TR (NCT04097145)
- Testing
- Edwards PASCAL System, Optimal Medical Therapy
- Where
- 79 sites in United States, Canada
- Volunteers
- 1,270 people
- Sponsor
- Edwards Lifesciences
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Replacement
Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve…
- Trial name
- CAVALIER (NCT01368666)
- Testing
- Perceval S Valve Prosthesis
- Where
- 26 sites in Austria, Belgium and 6 more
- Volunteers
- 658 people
- Sponsor
- Corcym S.r.l
Obstructive Hypertrophic Cardiomyopathy
Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy
This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated.
- Trial name
- NCT06368037
- Testing
- DragonFire Transcatheter Myocardial Radiofrequency Ablation System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Valve Insufficiency
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- NCT02607527
- Testing
- Mitral Valve IRIS Ring
- Where
- 2 sites in Brazil, Paraguay
- Volunteers
- 21 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy
Viz HCM (ECG Assist) Utilization Workflow Pilot
This is a prospective, open-label, multi-center workflow pilot. Viz HCM will be implemented at each participating site and all conforming incoming ECG recordings within a 6-month enrollment period will be analyzed using Viz HCM.
- Trial name
- NCT06600256
- Testing
- Viz HCM ECG Review, Baseline Effectiveness Cohort
- Where
- 5 sites in United States
- Volunteers
- 217 people
- Sponsor
- Viz.ai, Inc.
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb