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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Mitral Regurgitation; Tricuspid Regurgitation; Mitral Repair
• Intervention / Treatment: Behavioral: Early discharge protocol

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures	Up to 3 months
Proportion of patients requiring intensive care unit care	The proportion of patients admitted to intensive care unit after their procedure	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	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)	During index admission up to 30 days post procedure.
Symptomatic improvement	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).	3 months, 1 year
Heart failure hospitalisation	Any heart failure related hospitalisations after the index procedure	30 days, 1 year

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Sam Dawkins, MBBS MRCP BSc DPhil, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: mitral regurgitation; tricuspid regurgitation; transcatheter edge-to-edge repair; mitral TEER
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency
• Other Study ID Numbers: 318352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes