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

Recruiting

• Conditions: Mitral Regurgitation; Tricuspid Regurgitation; Mitral Repair; Heart Failure
• Interventions: Behavioral: Early discharge protocol

• Registration Number: NCT06343363
• Lead Sponsor: Oxford University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with either mitral TEER, tricuspid TEER or both	Early discharge protocol	Patients treated with either mitral TEER, tricuspid TEER or both, at John Radcliffe Hospital, Oxford

Primary Outcome Measures

Name	Time	Method
All - cause rehospitalisation after completion of procedure	30 days, 1 year	Any hospital admission after discharge from the index procedure
All cause death after completion of procedure	30 days, 1 year	All patient death following discharge after the index procedure
Proportion of patients discharged 'early' after edge -to-edge repair	up to 30 days	defined as \< 36 hours after completion of procedure

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Up to 3 months	Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures
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.	Evaluating safety a. Major adverse events (procedure/device related) at the time of procedure b. Major adverse events (procedure/device related) up to 30 days (including unplanned surgery relating to a device/procedural complication)
Proportion of patients requiring intensive care unit care	Up to 3 months	The proportion of patients admitted to intensive care unit after their procedure
Heart failure hospitalisation	30 days, 1 year	Any heart failure related hospitalisations after the index procedure
Symptomatic improvement	3 months, 1 year	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from pre-procedure to post-procedure (validated score for assessing symptoms, physical and social limitations, and quality of life in patients with heart failure, score 0-100, where 100 = no symptoms).

Trial Locations

Locations (1)

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom