Clinical trials: Surgical Treatment for Heart Valve Diseases
Aortic Valve Stenosis
Medtronic CoreValve REDO Study
The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV…
- Trial name
- REDO (NCT01051310)
- Testing
- Medtronic CoreValve System
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 18 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Concomitant Treatment of Permanent Atrial Fibrillation
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
- Trial name
- RESTORE SR (NCT00566787)
- Testing
- Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
- Where
- 10 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation, Mitral Valve Insufficiency
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation.
- Conditions
- Atrial Fibrillation, Mitral Valve Insufficiency, Mitral Valve Stenosis
- Trial name
- NCT00903370
- Testing
- MVS, Ablation
- Where
- 21 sites in United States, Canada
- Volunteers
- 260 people
- Sponsor
- Annetine Gelijns
Rheumatic Valve Disease, Atrial Fibrillation
Efficiency of Radiofrequency Ablation for Surgical Treatment of Chronic Atrial Fibrillation With Rheumatic Valve Disease
The purpose of this study is to determine whether concomitant radiofrequency Maze procedure for surgical treatment of chronic atrial fibrillation with rheumatic valve disease could provide better sinus rhythm control, improved…
- Trial name
- NCT01013688
- Testing
- Cardioblate® Surgical Ablation System
- Where
- China
- Volunteers
- 150 people
- Sponsor
- China National Center for Cardiovascular Diseases
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Valvular Heart Disease
Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery.
- Trial name
- SAVR-CT-AVA (NCT07125469)
- Testing
- The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- Maria Cecilia Hospital
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Atrial Fibrillation
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
- Trial name
- NCT01107730
- Testing
- Vitamin C, L-Carnitine
- Where
- Greece
- Volunteers
- 33 people
- Sponsor
- Attikon Hospital
Mitral Regurgitation (MR), Pediatric Cardiac Surgery
A Prospective Multicenter Cohort Study on Surgical Treatment Strategies for Pediatric Mitral Regurgitation
This prospective, multicenter cohort study aims to evaluate the outcomes of surgical repair for pediatric mitral regurgitation (MR) in China.
- Trial name
- NCT07284212
- Testing
- conventional mitral valve repair, standardized mitral valve repair
- Where
- China
- Volunteers
- 427 people
- Sponsor
- China National Center for Cardiovascular Diseases
Severe Aortic Valve Disease, Aortic Valve Replacement (AVR)
Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargement
Abstract Background: Aortic valve replacement (AVR) is crucial for patients with severe aortic valve disease. However, managing those with a small aortic annulus (SAA, i.e., annulus diameter < 22 mm) is challenging because…
- Conditions
- Severe Aortic Valve Disease, Aortic Valve Replacement (AVR), Small Aortic Annulus
- Trial name
- CRYSTAL (NCT07368322)
- Testing
- Y incision Technique (YIT), Standard surgical enlargement techniques
- Where
- Israel
- Volunteers
- 90 people
- Sponsor
- willner nadav MD
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Myocardial Infarction, Mitral Regurgitation
Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention
The pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following Percutaneous Coronary Intervention (PCI) for…
- Trial name
- NCT01156441
- Testing
- surgical mitral valve repair w/ mitral valve annuloplasty
- Where
- United States
- Sponsor
- Southern Illinois University
Mitral Regurgitation
Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary…
- Trial name
- MITRA-HR (NCT03271762)
- Testing
- percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW, cardiac surgery
- Where
- 31 sites in France
- Volunteers
- 330 people
- Sponsor
- Nantes University Hospital
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.
Persistent Atrial Fibrillation
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation
This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.
- Trial name
- NCT05021601
- Testing
- Bi-atrial ablation, Left atrial ablation
- Where
- 2 sites in China
- Volunteers
- 320 people
- Sponsor
- China National Center for Cardiovascular Diseases
Stenoses, Aortic Valve
REPRISE China - Clinical Evaluation in China
To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high…
- Trial name
- NCT03084510
- Testing
- Lotus Edge™ Valve System
- Where
- China
- Sponsor
- Boston Scientific Corporation
Mitral Valve Regurgitation
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation…
- Trial name
- PRIMARY (NCT05051033)
- Testing
- Mitral valve repair, Transcatheter edge-to-edge repair
- Where
- 66 sites in United States, Canada and 3 more
- Volunteers
- 450 people
- Sponsor
- Annetine Gelijns
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Aortic Regurgitation, Aortic Valve Insufficiency
ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy
The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency
- Trial name
- ART (NCT07453407)
- Testing
- J-VALVE Transfemoral Aortic Valve system, Commercially available surgical biological aortic valve replacement device
- Where
- 28 sites in China
- Volunteers
- 1,250 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Right Ventricular Dysfunction
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve…
- Trial name
- NCT05804240
- Testing
- 3D TEE RVEF
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Thomas Jefferson University