Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety

NCT ID: NCT06343363

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-02-11

Brief Summary

Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.

Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.

This prospective, observational cohort study will examine the safety and feasibility of this practice.

Conditions

Mitral Regurgitation; Tricuspid Regurgitation; Mitral Repair; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients treated with either mitral TEER, tricuspid TEER or both

Patients treated with either mitral TEER, tricuspid TEER or both, at John Radcliffe Hospital, Oxford

Early discharge protocol

Intervention Type: BEHAVIORAL

Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours

Interventions

Early discharge protocol

Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years
• Accepted by Heart Team for TEER (mitral and/or tricuspid)
• Willing and able to give informed consent for participation in the study.
• Regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography
• Patient is willing and able to attend all follow-up visits

Exclusion Criteria

• Patients in whom safety or clinical concerns preclude participation
• Patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent)
• Patient in whom a TOE is contraindicated, or screening TOE is unsuccessful
• Pregnant or planning pregnancy within next 12 months
• Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
• Patients requiring emergency TEER

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Sam Dawkins

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sam Dawkins, MBBS MRCP BSc DPhil

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

318352

Identifier Type: -

Identifier Source: org_study_id