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OpenTrials
Completed

NCT Number: NCT06343363

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

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Mitral Repair Mitral Valve Insufficiency Tricuspid Regurgitation Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early discharge protocol

Behavioral

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

Primary outcomes

  1. Proportion of patients discharged 'early' after edge -to-edge repair

    Time frame: up to 30 days

    defined as < 36 hours after completion of procedure

  2. All - cause rehospitalisation after completion of procedure

    Time frame: 30 days, 1 year

    Any hospital admission after discharge from the index procedure

  3. All cause death after completion of procedure

    Time frame: 30 days, 1 year

    All patient death following discharge after the index procedure

Secondary outcomes

  1. Hospital length of stay

    Time frame: Up to 3 months

    Length of hospital stay from admission to discharge for outpatient procedures, or from procedure to discharge for inpatient procedures

  2. Proportion of patients requiring intensive care unit care

    Time frame: Up to 3 months

    The proportion of patients admitted to intensive care unit after their procedure

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

    Time frame: 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)

  4. Symptomatic improvement

    Time frame: 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).

  5. Heart failure hospitalisation

    Time frame: 30 days, 1 year

    Any heart failure related hospitalisations after the index procedure

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Collaborators

  • Edwards Lifesciences

Registry information

Acronym: EARLY-Edge

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2024
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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