Clinical trials: Heart Disease, Valvular
Mitral Regurgitation
The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- The REsOLVE Tr (NCT07450911)
- Testing
- ReValve System
- Where
- 3 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- ReValve Solutions Inc.
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
Mitral Regurgitation
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
- Trial name
- NCT07086534
- Testing
- GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Sierra Valve LLC
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
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI
Tricuspid Regurgitation
A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation
This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe…
- Trial name
- TANDEM I (NCT05296148)
- Testing
- Transcatheter Tricuspid Valve Implantation
- Where
- 3 sites in Poland
- Volunteers
- 10 people
- Sponsor
- CroiValve Limited
Heart Valve Diseases
ATS 3f(r) Aortic Bioprosthesis Model 1000, 19mm
The initial clinical investigation titled "ATS 3f(r) Aortic Bioprosthesis Model 1000 Study," was a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness obtained from 800 patient…
- Trial name
- NCT00657826
- Testing
- ATS 3f® Aortic Bioprosthesis, Model 1000, 19mm
- Where
- 2 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiovascular
Diseases of Aortic Valve, Aortic Regurgitation Disease
Clinical Trial in China
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic regurgitation disease who are at high or prohibitive surgical…
- Trial name
- NCT05580952
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in China
- Volunteers
- 120 people
- Sponsor
- Genesis Medtech Corporation
Cardiopulmonary Failure, Myocardial Infarction (MI)
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using…
- Conditions
- Cardiopulmonary Failure, Myocardial Infarction (MI), Heart Decompensation, Heart Failure
- Trial name
- COR-INSIGHT (NCT06763549)
- Testing
- SUBPROTOCOL A, SUBPROTOCOL B, SUBPROTOCOL C
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Atrial Fibrillation, Stroke
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
- Trial name
- NCT00262600
- Testing
- warfarin, Dabigatran dose 1, Dabigatran dose 2
- Where
- 984 sites in United States, Argentina and 42 more
- Volunteers
- 18,113 people
- Sponsor
- Boehringer Ingelheim
Mitral Regurgitation
EFS of the CardioMech MVRS
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
- Trial name
- NCT04820764
- Testing
- CardioMech MVRS
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- CardioMech AS
Aortic Stenosis, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
- Trial name
- REMAP-HCM (NCT07846059)
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Bristol-Myers Squibb
Mitral Valve Disease, Mitral Valve Stenosis
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance.
- Conditions
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- Trial name
- FOLDAX (NCT04717570)
- Testing
- Foldax TRIA Mitral Valve
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Foldax, Inc
Hypertrophic Cardiomyopathy
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic hypertrophic cardiomyopathy (HCM) caused by…
- Trial name
- MyPEAK-1 (NCT05836259)
- Testing
- TN-201
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tenaya Therapeutics
Hypertrophic Obstructive Cardiomyopathy
First-in-Man Early Feasibility Study for Transcatheter HOCM Septal Ablation
Transcatheter Intra-septal RF ablation system (TIRA catheter with its supplemental devices) to treat hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT04770142
- Testing
- TIRA catheter
- Where
- 9 sites in South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Atrial Fibrillation
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists
The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.
- Trial name
- NCT02960880
- Testing
- Rivaroxaban (Xarelto, BAY597939), Phenprocoumon (branded and generics)
- Where
- Germany
- Volunteers
- 99,999 people
- Sponsor
- Bayer