Clinical trials: Cardiac Valve Annuloplasty
Atrial Functional Mitral Regurgitation, Heart Failure
Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)
To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
- Trial name
- AFRICA (NCT03453853)
- Testing
- Mitral Loop Cerclage Annuloplasty
- Where
- 7 sites in South Korea
- Volunteers
- 1 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Tricuspid (Valve) Insufficiency (Rheumatic)
PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be…
- Trial name
- PROCIDA (NCT03129737)
- Testing
- Mitral valve surgery, Tricuspid valve annuloplasty
- Where
- 8 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Ettore Sansavini Health Science Foundation
Tricuspid (Valve); Deformity
Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty
The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.
- Trial name
- NCT02357862
- Testing
- Mitral Valve Annuloplasty
- Volunteers
- 22 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid…
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT-II (NCT03225612)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in Germany, Italy and 2 more
- Volunteers
- 60 people
- Sponsor
- Mitralign, Inc.
Mitral Regurgitation, Coronary Artery Disease
Randomised Ischaemic Mitral Evaluation (RIME) Trial
The study is a randomised controlled trial comparing two treatment strategies for patients with moderate functional ischaemic mitral regurgitation undergoing coronary artery bypass grafting (CABG).
- Trial name
- RIME (NCT00413998)
- Testing
- CABG + Mitral valve annuloplasty, CABG
- Where
- 9 sites in Poland, United Kingdom
- Volunteers
- 73 people
- Sponsor
- Imperial College London
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Tricuspid Regurgitation, Tricuspid Insufficiency
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
- Trial name
- TriBAND (NCT03779490)
- Testing
- Transcatheter Tricuspid Valve Repair
- Where
- 14 sites in Germany, Spain and 1 more
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Tricuspid Valve Insufficiency
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed.
- Trial name
- NCT01532921
- Testing
- Tricuspid valve repair, Left-sided heart surgery, Contour 3D Tricuspid Annuloplasty Ring
- Where
- 7 sites in France, Germany and 1 more
- Volunteers
- 85 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Mitral Valve Insufficiency
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation.
- Trial name
- NCT01137734
- Testing
- Adjustable Annuloplasty Ring with option to adjust off pump., Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 30 people
- Sponsor
- Edwards Lifesciences
Symptomatic Functional MR 3 or Greater
AMEND TS Early Feasibility Study
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation.
- Trial name
- NCT06951672
- Testing
- This study will evaluate the safety and functionality of the AMEND™ Trans-Septal System for annuloplasty as a therapy for mitral regurgitation.
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Valcare Medical Ltd.
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
Mitral Regurgitation
Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?
Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy.
- Trial name
- NCT05836376
- Testing
- Mitral valve annuloplasty
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Michele De Bonis
Mitral Regurgitation
AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.
- Trial name
- NCT02602613
- Testing
- AMEND Mitral Valve Repair System
- Where
- 5 sites in Belgium, Czechia and 2 more
- Volunteers
- 4 people
- Sponsor
- Valcare Medical Ltd.
Mitral Regurgitation
Cardioband With Transfemoral Delivery System
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
- Trial name
- NCT01841554
- Testing
- Cardioband
- Where
- 11 sites in France, Germany and 4 more
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Heart Failure, Mitral Regurgitation
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
- Trial name
- PTOLEMY (NCT00571610)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Viacor
Mitral Valve Regurgitation, Congestive Heart Failure
Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
The primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyopathy who undergo mitral valve…
- Conditions
- Mitral Valve Regurgitation, Congestive Heart Failure, Cardiomyopathy
- Trial name
- NCT00428103
- Testing
- 3 dimensional echocardiography
- Where
- United States
- Sponsor
- Juan Crestanello, MD
Tricuspid Regurgitation
Band Versus Ring for Tricuspid Regurgitation
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly.
- Trial name
- NCT04093297
- Testing
- Tricuspid Annuloplasty
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Nanjing Medical University
Mitral Regurgitation, Heart Failure
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
- Trial name
- PTOLEMY2Canada (NCT00815386)
- Testing
- Percutaneous transvenous mitral annuloplasty
- Where
- 3 sites in Canada
- Volunteers
- 20 people
- Sponsor
- Viacor