Clinical trials: Heart Disease, Valvular
Mitral Regurgitation, Mitral Insufficiency
AltaValve Early Feasibility Study Protocol
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- NCT03997305
- Testing
- AltaValve
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- 4C Medical Technologies, Inc.
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.
Mitral Valve Insufficiency
MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States
The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Trial name
- MAVERIC US (NCT03311295)
- Testing
- ARTO System
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Mvrx, Inc.
Atrial Fibrillation, Hypertension
Validation Study of an Advanced Blood Pressure Monitor
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Trial name
- TALISMAN (NCT04030494)
- Testing
- BP measurement, AF detection, VHD detection
- Where
- France
- Volunteers
- 218 people
- Sponsor
- Withings
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Atrial Fibrillation
Real-world Dosing Patterns of Rivaroxaban in the United States
The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban.
- Trial name
- NCT03242278
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- United States
- Volunteers
- 12,507 people
- Sponsor
- Bayer
Tricuspid Regurgitation, Tricuspid Valve Disease
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve®…
- Trial name
- TRICAV-I (NCT06137807)
- Testing
- TricValve® Transcatheter Bicaval Valve System
- Where
- 36 sites in United States
- Volunteers
- 50 people
- Sponsor
- P+F Products + Features USA Inc.
Severe Aortic Stenosis
CoreValve Advance International Post Market Study
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
- Trial name
- NCT01074658
- Testing
- Medtronic CoreValve System
- Where
- 44 sites in Belgium, Colombia and 10 more
- Volunteers
- 1,015 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Valve Regurgitation (Degenerative or Functional)
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty…
- Trial name
- MARCH (NCT07188233)
- Testing
- Transcatheter Mitral Valve Repair
- Where
- 2 sites in Georgia, Lithuania
- Volunteers
- 5 people
- Sponsor
- HVR Cardio Oy
Mitral Regurgitation
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral…
- Trial name
- HRT (NCT03511716)
- Testing
- HRT Mitral Bridge Mitral Valve Repair
- Where
- Czechia
- Volunteers
- 34 people
- Sponsor
- Heart Repair Technologies, Inc.
Tricuspid Regurgitation
Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation.
- Trial name
- NCT03294200
- Testing
- TriCinch Coil System implantation
- Where
- 13 sites in Australia, Belgium and 5 more
- Volunteers
- 18 people
- Sponsor
- 4Tech Cardio Ltd.
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Mitral Valve Regurgitation, Mitral Regurgitation
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the…
- Trial name
- NCT03502811
- Testing
- MitraClip NTR/XTR System
- Where
- 57 sites in United States, Germany and 6 more
- Volunteers
- 1,041 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Stroke
Patient Convenience Study (RE-SONANCE)
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its…
- Trial name
- NCT02684981
- Where
- 12 sites in Austria, Bulgaria and 10 more
- Volunteers
- 9,472 people
- Sponsor
- Boehringer Ingelheim
Aortic Stenosis
Dedicated Sheath Feasibility Study
Dedicated Sheath feasibility study: A prospective, open-label study to evaluate the feasibility and safety of the Valve Medical Dedicated Sheath during Balloon Aortic Valvuloplasty (BAV).
- Trial name
- BAV (NCT02617524)
- Testing
- Valve Medical Dedicated Sheath version 00
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Valve Medical
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
Tricuspid Valve Insufficiency, Tricuspid Regurgitation
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement.
- Conditions
- Tricuspid Valve Insufficiency, Tricuspid Regurgitation, Tricuspid Valve Regurgitation, Cardiovascular Diseases
- Trial name
- TRI-REPAIR (NCT02981953)
- Testing
- Cardioband Tricuspid
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 40 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation
Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and…
- Trial name
- XaMINA (NCT03284762)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 2 sites in South Korea, Taiwan
- Volunteers
- 1,216 people
- Sponsor
- Bayer
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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