Clinical trial NCT06343363: Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
Official title: Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Tricuspid Regurgitation
Mitral Repair
Heart Failure
Keywords: transcatheter edge-to-edge repair
mitral TEER
mitral regurgitation
tricuspid regurgitation
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2024-04-02
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients discharged 'early' after edge -to-edge repair
timeFrame: up to 30 days
measure: All - cause rehospitalisation after completion of procedure
timeFrame: 30 days, 1 year
measure: All cause death after completion of procedure
timeFrame: 30 days, 1 year
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 3 months
measure: Proportion of patients requiring intensive care unit care
timeFrame: Up to 3 months
measure: Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days
timeFrame: During index admission up to 30 days post procedure.
measure: Symptomatic improvement
timeFrame: 3 months, 1 year
measure: Heart failure hospitalisation
timeFrame: 30 days, 1 year
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Sam Dawkins, MBBS MRCP BSc DPhil
role: PRINCIPAL_INVESTIGATOR
References: