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

NHS Trust

Status: Completed

Conditions: Mitral Repair; Mitral Regurgitation; Heart Failure; Tricuspid Regurgitation

Treatments: Behavioral: Early discharge protocol

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06343363

318352

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

127 participants in 1 patient group

Patients treated with either mitral TEER, tricuspid TEER or both

Description:

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

Treatment:

Behavioral: Early discharge protocol