Ignite Creation Date:
2025-12-18 @ 9:19 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT05403840
Status:
None
Last Update Posted:
2022-06-03 00:00:00
First Post:
2022-05-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Haemodynamics of Mitral Regurgitation Reduction
Sponsor:
None
Organization:
Study Overview
Official Title:
Comparative STudy chaRacterising the Physiological changEs Induced by Surgical and tranScatheter Mitral Regurgitation Reduction (STRESS-MR)
Status:
None
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
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:
STRESS-MR
Brief Summary:
Conventional surgery for mitral regurgitation (MR) in high risk patients is associated with reduced benefit and increased risk of perioperative complications.Percutaneous transcatheter intervention (edge to edge repair) is an alternative treatment option is associated with clinical benefit and reduced peri-procedural risk. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood.
This is a a prospective observational study, involving patients with severe MR undergoing mitral valve surgery (MVRR) and transcatheter intervention (TMVI) as standard of care being recruited into two separate cohorts. Patients will undergo investigations at baseline, in hospital post-operative, and at 6 months to characterise cardiac structure and function.
This is a a prospective observational study, involving patients with severe MR undergoing mitral valve surgery (MVRR) and transcatheter intervention (TMVI) as standard of care being recruited into two separate cohorts. Patients will undergo investigations at baseline, in hospital post-operative, and at 6 months to characterise cardiac structure and function.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: