NCT05403840

Haemodynamics of Mitral Regurgitation Reduction

Comparative STudy chaRacterising the Physiological changEs Induced by Surgical and tranScatheter Mitral Regurgitation Reduction (STRESS-MR)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is uncertainty in terms of the superiority of conventional valve surgery or percutaneous transcatheter intervention for the treatment of severe mitral regurgitation (MR) in high risk patients. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood. This study seeks to characterise the physiological changes and functional outcomes of patients undergoing either surgery or transcatheter intervention.

Detailed description

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.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
PROCEDURE	Mitral valve surgery	Surgical mitral valve repair or replacement
PROCEDURE	Transcatheter mitral valve intervention	Transcatheter mitral valve repair or replacement

Timeline

• Start date: 2022-06-06
• Primary completion: 2024-06-06
• Completion: 2025-01-06
• First posted: 2022-06-03
• Last updated: 2022-06-03