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

NCT06343363 | Completed

• 1 other identifier: 318352
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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

Keywords

transcatheter edge-to-edge repair; mitral TEER; mitral regurgitation; tricuspid regurgitation

Outcome Measures

Primary Outcomes (3)

• Proportion of patients discharged 'early' after edge -to-edge repair

  defined as \< 36 hours after completion of procedure

  up to 30 days

• All - cause rehospitalisation after completion of procedure

  Any hospital admission after discharge from the index procedure

  30 days, 1 year

• All cause death after completion of procedure

  All patient death following discharge after the index procedure

  30 days, 1 year

Secondary Outcomes (5)

• Hospital length of stay

  Up to 3 months

• Proportion of patients requiring intensive care unit care

  Up to 3 months

• Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days

  During index admission up to 30 days post procedure.

• Symptomatic improvement

  3 months, 1 year

• Heart failure hospitalisation

  30 days, 1 year

Study Arms (1)

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

Behavioral: Early discharge protocol

Interventions

Early discharge protocol BEHAVIORAL

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

Patients treated with either mitral TEER, tricuspid TEER or both

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged ≥18 years referred for either mitral or tricuspid TEER (or both) and found to be eligible candidates after review by the Oxford Heart Team.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Edwards Lifesciences: collaborator

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Sam Dawkins, MBBS MRCP BSc DPhil

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: April 2, 2024
• Study Start: May 1, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)