Clinical trials: Mitral Disease
Mitral Valve Repair, Mitral Regurgitation
ChordArt System for Mitral Regurgitation
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach.
- Conditions
- Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency
- Trial name
- CHAGALL (NCT03581656)
- Testing
- ChordArt System
- Where
- Lithuania
- Volunteers
- 5 people
- Sponsor
- CoreMedic GmbH
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Disease, Damaged Mitral Valve
HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially…
- Conditions
- Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement
- Trial name
- NCT02097420
- Testing
- Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
- Where
- 24 sites in United States
- Volunteers
- 23 people
- Sponsor
- Abbott Medical Devices
Degenerative Mitral Valve Disease
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of symptomatic moderate-to-severe(3+) or severe(4+) degenerative mitral regurgitation (DMR) in high surgical risk…
- Trial name
- NCT04734756
- Testing
- Dragonfly Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Regurgitation
Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation.
- Trial name
- EXERCISE FMR (NCT05040451)
- Testing
- Carillon Mitral Contour System
- Sponsor
- Cardiac Dimensions Pty Ltd
Mitral Valve Regurgitation
Mitral Valve Replacement With MValve Dock and Lotus
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.
- Trial name
- DOCK 1 (NCT02719912)
- Testing
- mitral valve replacement
- Where
- 4 sites in Brazil, France and 2 more
- Volunteers
- 30 people
- Sponsor
- MValve Technologies Ltd
Mitral Regurgitation
Safety and Performance Study of the MitralStitch Repair System.
The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.
- Trial name
- NCT04080362
- Testing
- MitralStitch
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Mitral Regurgitation
Cephea Transseptal Mitral Valve System FIH
To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for…
- Trial name
- NCT03988946
- Testing
- Transcatheter Mitral Valve Replacement via Transseptal Access
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Cephea Valve Technologies
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Mitral Regurgitation
Anchord Mitral Chordal Repair System - FIH
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal…
- Trial name
- NCT07671820
- Testing
- Anchord device implantation
- Volunteers
- 5 people
- Sponsor
- Lifecord Otd
Mitral Valve Prolapse
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
- Trial name
- SJM PMVr (NCT01500148)
- Testing
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Regurgitation
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
- Trial name
- DYANA (NCT00833014)
- Testing
- Dynamic Annuloplasty Ring (with option to adjust off-pump)
- Where
- 5 sites in Canada, Germany and 1 more
- Volunteers
- 130 people
- Sponsor
- MiCardia Corporation
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Mitral Valve Insufficiency
CG Future® Annuloplasty Ring/Band Clinical Trial
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
- Trial name
- NCT01074671
- Testing
- CG Future Annuloplasty Ring/Band
- Where
- 8 sites in Belgium, Germany and 3 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the…
- Trial name
- NCT05417945
- Testing
- JensClip transcatheter valve repair system
- Volunteers
- 124 people
- Sponsor
- Jenscare Scientific
Mitral Valve Insufficiency
Multicenter International Trial Ring AnnulopLasty
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included.
- Trial name
- MITRAL (NCT00727012)
- Testing
- mitral valve repair (SJM® Rigid Saddle Ring)
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation, Mitral Valve Disease
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation
Early feasibility study, single-arm registry design
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency
- Trial name
- EXPLORE MR (NCT04098328)
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 2 people
- Sponsor
- Polares Medical SA
Mitral Valve Insufficiency
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when…
- Trial name
- ReChord (NCT02803957)
- Testing
- NeoChord DS1000, Surgical Mitral Valve Repair
- Where
- 14 sites in United States
- Volunteers
- 585 people
- Sponsor
- NeoChord
Mitral Valve Regurgitation
Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Trial name
- MAVERIC (NCT02302872)
- Testing
- ARTO System
- Where
- 9 sites in Australia, France and 3 more
- Volunteers
- 51 people
- Sponsor
- Mvrx, Inc.