Degenerative Mitral Valve Disease Clinical Trial
Official title:
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation (EXPLORE DMR)
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.
Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery. Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical PLAR Implant and Delivery System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The PLAR Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03290872 -
Mitral Annuloplasty Rings RCT
|
N/A | |
| Completed |
NCT05774769 -
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
|
||
| Completed |
NCT05839782 -
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
|
||
| Completed |
NCT05836532 -
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
|
||
| Recruiting |
NCT03706833 -
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
|
N/A | |
| Recruiting |
NCT05655897 -
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
|
N/A | |
| Enrolling by invitation |
NCT04734756 -
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
|
N/A | |
| Enrolling by invitation |
NCT04067635 -
Primary Mitral Regurgitation Repair
|
||
| Active, not recruiting |
NCT06021509 -
Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation
|
N/A | |
| Active, not recruiting |
NCT04281940 -
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
|
N/A | |
| Not yet recruiting |
NCT05417945 -
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
|
N/A | |
| Recruiting |
NCT03433274 -
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
|
N/A | |
| Active, not recruiting |
NCT03674593 -
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
|
N/A | |
| Recruiting |
NCT05595226 -
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
|
N/A | |
| Terminated |
NCT04666480 -
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
|
N/A |