Clinical trial NCT05403840: Haemodynamics of Mitral Regurgitation Reduction
Official title: Comparative STudy chaRacterising the Physiological changEs Induced by Surgical and tranScatheter Mitral Regurgitation Reduction (STRESS-MR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
name: Royal Brompton & Harefield NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic severe mitral regurgitation accepted for either surgery or transcatheter valve intervention as standard of care and judged to be at high or prohibitive surgical risk.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in left ventricular efficiency as measured by ventricular arterial coupling
timeFrame: From baseline to immediately following intervention and 6 months follow up
Secondary outcomes:
measure: Change in Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: Baseline to 6 months post intervention
measure: Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
timeFrame: From baseline to immediately following intervention and 6 months follow up
measure: Residual Mitral Regurgitation (MR) Severity
timeFrame: Immediately following intervention and 6 months follow up
measure: Change in New York Heart Association (NYHA) Functional Class
timeFrame: Baseline to 6 months follow up
measure: Change in Six Minute Walk Test (6MWT Distance or 6MWD)
timeFrame: Baseline to 6 months follow up
measure: Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Baseline to 6 months follow up
Other outcomes:
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