Clinical trials: Heart Disease, Valvular
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Heart Failure, Mitral Valve Insufficiency
Safety and Performance of the AccuCinch® System
This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral…
- Trial name
- NCT02624960
- Testing
- Accucinch Implant
- Sponsor
- Ancora Heart, Inc.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
The purpose of this study is to evaluate the real-world safety and effectiveness of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) initiated on mavacamten at certain high volume HCM centers in the US
- Trial name
- NCT07107373
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Bristol-Myers Squibb
Mitral Valve Regurgitation
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.
- Trial name
- ALIGN (NCT01740583)
- Testing
- percutaneous annuloplasty
- Where
- 8 sites in Colombia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Mitralign, Inc.
Healthy Participants
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05362045
- Testing
- Mavacamten
- Where
- 4 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Severe Tricuspid Regurgitation
TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device
The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk…
- Trial name
- NCT04141137
- Testing
- TricValve® System
- Where
- 10 sites in Austria, Spain
- Volunteers
- 35 people
- Sponsor
- P+F Products + Features GmbH
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based…
- Trial name
- ELIMINATE-AF (NCT02942576)
- Testing
- Edoxaban, VKA-Based Regimen
- Where
- 75 sites in Belgium, Canada and 9 more
- Volunteers
- 632 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Heart Valve Diseases
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00876525
- Testing
- Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 702 people
- Sponsor
- Corcym S.r.l
Heart Valve Disease
Randomized On-X Anticoagulation Trial
Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently…
- Trial name
- PROACT (NCT00291525)
- Testing
- On-X valve using reduced anticoagulation, On-X Valve with Standard warfarin Therapy
- Where
- 49 sites in United States, Canada
- Volunteers
- 977 people
- Sponsor
- On-X Life Technologies, Inc.
Aortic Valve Stenosis
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery…
- Trial name
- NCT01238835
- Testing
- SAPIEN XT™ Transapical aortic valve replacement
- Where
- 20 sites in Austria, France and 2 more
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
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…
- Trial name
- NCT05556460
- Testing
- DragonFly-T Transcatheter Tricuspid Valve Repair System, Medical therapy
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Valve Regurgitation
Expanded Clinical Study of the Tendyne Mitral Valve System
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II…
- Trial name
- NCT02321514
- Testing
- Tendyne Mitral Valve System
- Where
- 40 sites in United States, Australia and 8 more
- Volunteers
- 191 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation, Tricuspid Valve Disease
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).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA-US (NCT05848284)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 11 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- VDyne, Inc.
Mitral Regurgitation (MR)
Early Feasibility Study of the Capstan Medical TMVR System
This early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral…
- Trial name
- NCT07917208
- Testing
- Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Capstan Medical
Mitral Valve Regurgitation, Mitral Valve Insufficiency
HighLife™ Transcatheter Mitral Valve Replacement System Study
Multicenter feasibility study of the HighLife™ TMVR system.
- Trial name
- NCT02974881
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 10 sites in France, Germany
- Volunteers
- 5 people
- Sponsor
- HighLife SAS
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Aortic Valve Stenosis, Aortic Valve Failure
Portico Valve-in-Valve Retrospective Registry
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05002088
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 7 sites in Australia, Denmark and 2 more
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices