Clinical trials: Heart Valve Diseases
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Intracranial Embolism and Thrombosis
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI…
- Trial name
- NAUTILUS (NCT04704258)
- Testing
- TAVI (Transcatheter Aortic Valve Implant), FLOWer Embolic Protection System
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 100 people
- Sponsor
- AorticLab Srl
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
Coronary Disease, Valve Heart Disease
Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients
During percutaneous cardiovascular intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter.
- Conditions
- Coronary Disease, Valve Heart Disease, Pacemaker DDD
- Trial name
- NCT04372654
- Testing
- Electroducer Sleeve
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Electroducer
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
VitaFlowTM II Transcatheter Aortic Valve System Study
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic…
- Trial name
- NCT03575039
- Testing
- VitaFlow II Transcatheter Aortic Valve System
- Volunteers
- 178 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Aortic Stenosis
REPRISE Next Generation Delivery System
To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are…
- Trial name
- NGDS (NCT02329496)
- Testing
- Lotus Valve and LOTUS Edge Valve System
- Where
- 2 sites in Australia
- Volunteers
- 38 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
Hydra Registry - UK
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the…
- Trial name
- NCT06507579
- Testing
- Hydra transcatheter aortic valve (THV) series
- Where
- 4 sites in United Kingdom
- Volunteers
- 250 people
- Sponsor
- Sahajanand Medical Technologies Limited
Atrial Fibrillation, Atrial Flutter
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease, Myocardial Infarction
- Trial name
- EmbraceAC (NCT00691470)
- Testing
- ATI-5923, Coumadin (warfarin)
- Where
- 41 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARYx Therapeutics
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
Heart Valve Diseases
Dabigatran Etexilate in Patients With Mechanical Heart Valves
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Trial name
- RE-ALIGN (NCT01452347)
- Testing
- warfarin 1mg, dabigatran etexilate intermediate dose, dabigatran etexilate low dose
- Where
- 40 sites in Belgium, Canada and 8 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Mitral Insufficiency, Heart Valve Disease
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered…
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02515539
- Testing
- CardiAQ TMVI System (Transapical & Transfemoral DS)
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
- Trial name
- NCT04068402
- Testing
- Vivio System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
The COAPT Continued Access Study (CAS) is an extension of the COAPT RCT under the same IDE (G120024). COAPT CAS was a single-arm, prospective, multicenter continued access registry that enrolled heart failure patients with…
- Trial name
- COAPT CAS (NCT07227675)
- Testing
- MitraClip® NT System
- Where
- 32 sites in United States
- Volunteers
- 162 people
- Sponsor
- Abbott Medical Devices
Venous Thromboembolism
Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacement, prevention or treatment…
- Trial name
- vMetrics-AMS (NCT00978445)
- Testing
- vMetrics protocol
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- ZIN Technologies, Inc.