Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05610566
Status:
RECRUITING
Last Update Posted:
2022-11-09
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
Sponsor:
Peijia Medical Technology (Suzhou) Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: