Clinical trials: Percutaneous Repair
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 Regurgitation
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- TRIBUTE (NCT05767645)
- Testing
- Mistral Procedure
- Where
- Israel
- Volunteers
- 75 people
- Sponsor
- Mitralix
PFO, PFO - Patent Foramen Ovale
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a…
- Conditions
- PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale
- Trial name
- PROTEA-PFO (NCT07172464)
- Testing
- Recross P3 Occluder (P3O) System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Recross Cardio, Inc.
Functional Mitral Regurgitation
Mitralign Percutaneous Annuloplasty First in Man Study
The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation.
- Trial name
- NCT01852149
- Testing
- MPAS Implant
- Where
- 5 sites in Brazil, Germany and 1 more
- Volunteers
- 35 people
- Sponsor
- Mitralign, Inc.
Tricuspid Regurgitation
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation. It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and…
- Trial name
- PREVENT (NCT02098200)
- Testing
- TriCinch System
- Where
- 14 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- 4Tech Cardio Ltd.
Aortic Diseases
Percutaneous Endovascular Arch Repair Trial (PEART) Study
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
- Trial name
- NCT05872282
- Testing
- ZIPPER aortic arch stentgraft system
- Where
- 3 sites in China
- Volunteers
- 24 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Mitral Regurgitation
MitraClip System in Australia and New Zealand
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the…
- Trial name
- MitraClipANZ (NCT01301625)
- Testing
- MitraClip Implant
- Where
- 6 sites in Australia
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Tricuspid Valve Regurgitation
MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- NCT04073979
- Testing
- Mistral implantation
- Where
- 4 sites in Germany
- Volunteers
- 9 people
- Sponsor
- Mitralix
Mitral Valve Regurgitation
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve…
- Trial name
- NCT04198870
- Testing
- MitraClip™ device implantation, Mitral Valve Repair Surgery
- Where
- 74 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Functional Mitral Regurgitation, Mitral Regurgitation
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon®…
- Trial name
- CINCH-FMR (NCT05677568)
- Testing
- Carillon Mitral Contour System
- Where
- 19 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Valve Regurgitation
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation
- Trial name
- CINCH-2 (NCT00800046)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Ancora Heart, Inc.
Tricuspid Valve Regurgitation
MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- NCT04071652
- Testing
- Mistral implantation
- Where
- 3 sites in Israel
- Volunteers
- 17 people
- Sponsor
- Mitralix
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.
Mitral Valve Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Tricuspid Regurgitation Functional
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following…
- Trial name
- NCT04890821
- Testing
- CI Percutaneous Ring Annuloplasty System
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
Mitral Valve Regurgitation
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation.
- Trial name
- MERIT (NCT02948231)
- Testing
- Mistral implantation
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Mitralix
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.
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix