Haemodynamics of Mitral Regurgitation Reduction (STRESS-MR)

Guy's and St Thomas' NHS Foundation Trust

Status: Not yet enrolling

Conditions: Mitral Regurgitation

Treatments: Procedure: Transcatheter mitral valve intervention; Procedure: Mitral valve surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05403840

1.4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe mitral regurgitation as per European Society of Cardiology guidelines
• Patients undergoing MVRR or TMVI as standard of care
• Patients at high, prohibitive surgical risk as judged by the Heart Team

Exclusion criteria

• Pregnancy and patients under the age of 18 years
• Congenital heart disease
• Moderate or severe mitral stenosis, aortic, pulmonary valve disease
• Patients currently enrolled in any other study where involvement in this study would involve deviation from either protocol

Trial design

60 participants in 2 patient groups

MVRR: Patients due to undergo surgical MV repair/replacement

Treatment:

Procedure: Mitral valve surgery

TMVI: Patients due to undergo transcatheter MV intervention

Treatment:

Procedure: Transcatheter mitral valve intervention