Functional Mitral Regurgitation Clinical Trial
Official title:
A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in Patients With Moderate-severe or Severe Functional MR (FMR)
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.
This study is a prospective, multi-center, single arm clinical study designed to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR (Functional MR) who still have symptoms after adequate treatment. This trial will be conducted at 41 sites in China and is planned to include a total of 118 subjects. All subjects received the trial device for transcatheter mitral valve clip delivery system and steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after surgery. The composite endpoint of all-cause death and hospitalization for heart failure was assessed at 12 months after surgery. After the 12th month follow-up, the statistical analysis, clinical summary and application for product registration were carried out. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02520310 -
AVJ-514 Japan Trial
|
N/A | |
Not yet recruiting |
NCT04396379 -
Epicardial Mitral Touch System for Mitral Insufficiency
|
N/A | |
Not yet recruiting |
NCT05566340 -
Treatment of Moderate FMR During AVR
|
||
Completed |
NCT01899573 -
Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function
|
N/A | |
Terminated |
NCT04529928 -
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
|
N/A | |
Recruiting |
NCT03706833 -
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
|
N/A | |
Completed |
NCT00800046 -
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
|
N/A | |
Active, not recruiting |
NCT03929913 -
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study
|
N/A | |
Recruiting |
NCT03616678 -
VenTouch OUS Feasibility Study
|
N/A | |
Not yet recruiting |
NCT04679714 -
EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation
|
N/A | |
Active, not recruiting |
NCT02701972 -
Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR
|
N/A | |
Enrolling by invitation |
NCT04776798 -
Biomechanical Taping on Low Back Pain With Increased Foot Pronation
|
N/A | |
Enrolling by invitation |
NCT05677568 -
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
|
||
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 | |
Completed |
NCT05865938 -
PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
|
||
Terminated |
NCT03016975 -
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
|
N/A | |
Completed |
NCT02471664 -
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
|
N/A | |
Active, not recruiting |
NCT02671799 -
Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)
|
N/A | |
Recruiting |
NCT03142152 -
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR
|
N/A | |
Completed |
NCT05774808 -
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
|