Clinical trials: AORTIC VALVE DISEASES
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis Symptomatic
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic…
- Trial name
- NCT06680427
- Testing
- Siegel Transcatheter Aortic Valve (TAVR)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- MiRus
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
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
AORTIC VALVE DISEASES, Aortic Valve Stenosis
Clinical Investigation for the PoliaValve Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the HeartHill PoliaValve Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT07123766
- Testing
- PoliaValve (Aortic)
- Volunteers
- 50 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Heart Valve Diseases, Aortic Valve Disease
Rapid Non-invasive Detection of Aortic Stenosis
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from…
- Conditions
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
- Trial name
- NCT04024566
- Testing
- Vivio System
- Where
- United States
- Sponsor
- Ventric Health, LLC
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 Valve Stenosis
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients.
- Trial name
- NCT02434263
- Testing
- Hydra TAVI
- Where
- 6 sites in Greece, Hong Kong and 4 more
- Volunteers
- 165 people
- Sponsor
- Vascular Innovations Co. Ltd.
Obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM
Mavacamtenis a novel, small molecule, selective allosteric inhibitor of cardiac-specific myosin, for the treatment of patients with symptomatic oHCM.
- Trial name
- NCT05174416
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 81 people
- Sponsor
- LianBio LLC
Aortic Valve Stenosis, Aortic Valve Insufficiency
Enable I Long-term Follow-up Study
This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous…
- Trial name
- NCT01636648
- Testing
- Aortic Valve Replacement
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 42 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme…
- Trial name
- NCT02746809
- Testing
- CoreValve Evolut 34R TAVR system
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Medtronic Cardiovascular
Hypertrophic Cardiomyopathy
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and improving ventricular compliance.
- Trial name
- NCT05135871
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- LianBio LLC
Aortic Valve Stenosis
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic…
- Trial name
- True™Flow (NCT02847546)
- Testing
- True™ Flow Valvuloplasty Perfusion Catheter
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- C. R. Bard
Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
- Conditions
- Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Trial name
- SGPV (NCT01092442)
- Testing
- Echocardiogram
- Where
- 8 sites in United States
- Volunteers
- 140 people
- Sponsor
- CryoLife, Inc.
Calcific Aortic Valve Disease
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 2 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with…
- Trial name
- NCT05143177
- Testing
- Evogliptin
- Where
- 25 sites in United States, Canada
- Volunteers
- 486 people
- Sponsor
- REDNVIA Co., Ltd.
Obstructive Hypertrophic Cardiomyopathy
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic…
- Trial name
- DISCOVER-HCM (NCT05489705)
- Testing
- Mavacamten, Non-mavacamten symptomatic oHCM therapy
- Where
- 101 sites in United States, Austria and 7 more
- Volunteers
- 1,700 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation