Clinical trials: Valvular Heart Disease Patients
Mitral Regurgitation Functional
Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk.
- Trial name
- One-Plus-One (NCT03503851)
- Testing
- MitraClip implantation
- Sponsor
- Asklepios proresearch
Atrial Fibrillation, Heart Failure
Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners
- Trial name
- NCT03508271
- Testing
- Non-Interventional
- Where
- United States
- Volunteers
- 60,000 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice
This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as…
- Trial name
- SiERRA UK (NCT03847181)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Warfarin
- Where
- United Kingdom
- Volunteers
- 45,164 people
- Sponsor
- Bayer
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
Aortic Valve Stenosis
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
- Trial name
- NCT04893603
- Testing
- Transcatheter Aortic Valve System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chengdu Silara Meditech Inc.
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Obstructive Hypertrophic Cardiomyopathy
A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
- Trial name
- NCT07021976
- Testing
- HRS-1893 Tablets
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Pulmonary Regurgitation
VenusP-Valve Pivotal Study (PROTEUS STUDY)
A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction.
- Trial name
- PROTEUS (NCT06010563)
- Testing
- Transcatheter pulmonary valve implantation (TPVI), VenusP-ValveTM System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Mitral Valve Insufficiency
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- NCT02607527
- Testing
- Mitral Valve IRIS Ring
- Where
- 2 sites in Brazil, Paraguay
- Volunteers
- 21 people
- Sponsor
- Boston Scientific Corporation
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Aortic Valve Disease
PAR I - Patient-to-Annulus Relation I
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for the prediction of hemodynamic outcome.
- Trial name
- PARI (NCT02981004)
- Where
- 7 sites in Germany
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).
- Trial name
- NCT00494871
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- 165 sites in Japan
- Volunteers
- 1,280 people
- Sponsor
- Bayer
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
Obstructive Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
- Trial name
- NCT06516068
- Testing
- HRS-1893
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten in Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US
- Trial name
- NCT07168655
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 163 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction
The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in…
- Trial name
- CALLIPER (NCT03359876)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin sodium
- Where
- United States
- Volunteers
- 16,000 people
- Sponsor
- Bayer
Atrial Fibrillation
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial…
- Trial name
- NCT00973245
- Testing
- Xarelto (Rivaroxaban, BAY59-7939), Warfarin
- Where
- 11 sites in Japan
- Volunteers
- 102 people
- Sponsor
- Bayer
Mitral Regurgitation
The PALMETTO Study
Prospective, single-arm, multicenter, non-randomized early feasibility study
- Trial name
- PALMETTO (NCT07885839)
- Testing
- ReValve System
- Volunteers
- 10 people
- Sponsor
- ReValve Solutions Inc.
Atrial Fibrillation
Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)
Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic…
- Trial name
- REATTAIN (NCT04249401)
- Testing
- Rivaroxaban (Xarelto), Apixaban, Dabigatran
- Where
- Sweden
- Volunteers
- 134,897 people
- Sponsor
- Bayer
Aortic Valve Stenosis, Aortic Valve Regurgitation
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic
- Trial name
- TAVIS (NCT05536310)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- JenaValve Technology, Inc.