Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02322840
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2014-10-31
Brief Title:
Transcatheter Mitral Valve Replacement System TMVR Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
Sponsor:
Medtronic Cardiovascular
Organization:
Medtronic Cardiovascular
Study Overview
Official Title:
An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Valve Replacement System in Patients With Severe Symptomatic Mitral Regurgitation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
PILOT
The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients
EFS
The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe Symptomatic Mitral Regurgitation
The study is pilot trial to evaluate the safety and performance of the Twelve TMVR System in very high risk mitral regurgitation patients
EFS
The study is an EFS trial to evaluate the safety and performance of the Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe Symptomatic Mitral Regurgitation
Detailed Description:
PILOT
The study is a prospective multi-center non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk patients with severe symptomatic mitral regurgitation who are deemed ineligible for standard surgery
EFS
The study is a multi-center prospective non-randomized trial to evaluate the safety and performance of the Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe Symptomatic Mitral Regurgitation
The study is a prospective multi-center non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high-risk patients with severe symptomatic mitral regurgitation who are deemed ineligible for standard surgery
EFS
The study is a multi-center prospective non-randomized trial to evaluate the safety and performance of the Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Moderate-Severe or Severe Symptomatic Mitral Regurgitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None