Haemodynamics of Mitral Regurgitation Reduction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-06

Study Completion Date

2025-01-06

Brief Summary

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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.

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Detailed Description

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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

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Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MVRR: Patients due to undergo surgical MV repair/replacement

Mitral valve surgery

Intervention Type PROCEDURE

Surgical mitral valve repair or replacement

TMVI: Patients due to undergo transcatheter MV intervention

Transcatheter mitral valve intervention

Intervention Type PROCEDURE

Transcatheter mitral valve repair or replacement

Interventions

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Mitral valve surgery

Surgical mitral valve repair or replacement

Intervention Type PROCEDURE

Transcatheter mitral valve intervention

Transcatheter mitral valve repair or replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No