Clinical trials: Cardiac Valve Disease
Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
Shenzhen Lifevalve Medical Scientific Co., Ltd. has developed a new X-Clip Mitral Valve Clip System and its compatible Steerable Guide System, aiming to provide transcatheter mitral valve repair for patients with degenerative…
- Trial name
- NCT07660185
- Testing
- X-Clip Treatment for Degenerative Mitral Regurgitation
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Shenzhen Lifevalve Medical Scientific Co., Ltd.
Aortic Valve Stenosis
RESPOND EDGE Post Market Study
The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially…
- Trial name
- RESPOND EDGE (NCT04009720)
- Testing
- Lotus Edge Device
- Where
- 13 sites in Denmark, Finland and 7 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Tricuspid Regurgitation
SQ-Kyrin-T First-in-man Feasibility Study
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with…
- Trial name
- NCT06605313
- Testing
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
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
Tricuspid Valve Regurgitation, Heart Valve Diseases
The TRICURE EFS Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRICURE EFS (NCT06506942)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 10 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- TRiCares
Heart Diseases, Aortic Stenosis, Severe
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
- Trial name
- EARLY TAVR (NCT03042104)
- Testing
- Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- Where
- 77 sites in United States, Canada
- Volunteers
- 901 people
- Sponsor
- Edwards Lifesciences
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Aortic Regurgitation
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some…
- Trial name
- NCT02732704
- Testing
- JenaValve Pericardial TAVR System
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases.
- Trial name
- NCT06181617
- Testing
- Quality of life assessment
- Where
- Japan
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
- Trial name
- CAPTURE-1 (NCT06103591)
- Testing
- The EmStop Embolic Protection System (EmStop System)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- EmStop Inc
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA
To evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at high risk for aortic valve replacement surgery.
- Trial name
- RADIANT CANADA (NCT02838680)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 2 sites in Canada
- Volunteers
- 15 people
- Sponsor
- HLT Inc.
Mitral Heart Valve Disease
Magna Mitral - 23mm
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
- Trial name
- NCT01312779
- Testing
- Implantation of CEP Magna Mitral Model 7000TFX
- Where
- 6 sites in United States, Poland
- Volunteers
- 39 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation (TR)
The TRICURE US IDE Pivotal Study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
- Trial name
- TRICURE US IDE (NCT07528326)
- Testing
- TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System
- Where
- United States
- Volunteers
- 831 people
- Sponsor
- TRiCares
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences
Aortic Regurgitation
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical…
- Trial name
- NCT06101888
- Testing
- TaurusTrio™ Heart Valve System
- Where
- 19 sites in China
- Volunteers
- 116 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
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