Clinical trials: Cardiac Valve Disease
Mitral Regurgitation
Safety and Performance Study of the MitralStitch Repair System.
The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.
- Trial name
- NCT04080362
- Testing
- MitralStitch
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Heart Failure, Mitral Regurgitation
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
- Trial name
- PTOLEMY (NCT00571610)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Viacor
Mitral Valve Regurgitation, Mitral Regurgitation
MitraClip EXPAND G4 Study
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
- Trial name
- NCT04177394
- Testing
- MitraClip G4 System
- Where
- 63 sites in United States, Canada and 8 more
- Volunteers
- 1,164 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Aortic Valve Disease
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
- Trial name
- NCT05295628
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS"), SENTINEL™ Cerebral Protection System
- Where
- 23 sites in United States
- Volunteers
- 532 people
- Sponsor
- Emblok, Inc.
Tricuspid Valve Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid…
- Trial name
- TriCLASP (NCT04614402)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System, Edwards PASCAL Precision Transcatheter Valve Repair System
- Where
- 15 sites in Germany, Greece and 2 more
- Volunteers
- 300 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Replacement
PERCEVAL Pivotal Trial
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community.
- Trial name
- NCT00860730
- Testing
- Aortic valve replacement with Perceval aortic heart valve
- Where
- 9 sites in Belgium, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Corcym S.r.l
Mitral Valve Insufficiency, Cardiac Valve Annuloplasty
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR).
- Conditions
- Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases
- Trial name
- REPAIR (NCT02703311)
- Testing
- Cardioband
- Where
- 10 sites in France, Germany and 1 more
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very 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 high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Cardiac Surgery, Coronary Artery Bypass Grafting
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or…
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Kidney Injury
- Trial name
- NCT00628264
- Testing
- AP214
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Action Pharma A/S
Non-obstructive Hypertrophic Cardiomyopathy
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
FORTITUDE-HCM is a global, multicenter, double-blind, parallel-group, placebo-controlled Phase 2b study that will assess the efficacy and safety of ninerafaxstat compared to placebo on top of Standard of Care in patients with…
- Trial name
- FORTITUDE-HCM (NCT07023614)
- Testing
- Ninerafaxstat 200mg MR
- Where
- 76 sites in United States, Austria and 9 more
- Volunteers
- 165 people
- Sponsor
- Imbria Pharmaceuticals, Inc.
Symptomatic Aortic Stenosis
Portico TAVI Implant With Transfemoral Delivery System
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
- Trial name
- NCT01493284
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 14 sites in Australia, Denmark and 3 more
- Volunteers
- 222 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation.
- Trial name
- MERIT (NCT02948231)
- Testing
- Mistral implantation
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Mitralix
Mitral Valve Regurgitation, Left Ventricular Dysfunction
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or…
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure, Mitral Insufficiency
- Trial name
- VIVID (NCT00512005)
- Testing
- Percutaneous mitral valve repair
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Myocor
Hypertrophic Cardiomyopathy
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with…
- Trial name
- LIBERTY-HCM (NCT02291237)
- Testing
- Eleclazine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
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
Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2.
- Trial name
- NCT04783766
- Testing
- CK-3773274
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals