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

Heart Failure Clinical Trial

— EARLY-Edge  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343363
• Other study ID #: 318352
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Oxford University Hospitals NHS Trust
• Contact: Sam Dawkins, MBBS MRCP BSc DPhil
• Phone: +443003047777
• Email: Sam.Dawkins[@]ouh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Mitral Regurgitation
• Mitral Repair
• Mitral Valve Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Behavioral:
• Early discharge protocol
Patients admitted for transcatheter edge-to-edge repair to either mitral or tricuspid valve and then discharged within 36 hours

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	Edwards Lifesciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients discharged 'early' after edge -to-edge repair	defined as < 36 hours after completion of procedure	up to 30 days
Primary	All - cause rehospitalisation after completion of procedure	Any hospital admission after discharge from the index procedure	30 days, 1 year
Primary	All cause death after completion of procedure	All patient death following discharge after the index procedure	30 days, 1 year
Secondary	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
Secondary	Proportion of patients requiring intensive care unit care	The proportion of patients admitted to intensive care unit after their procedure	Up to 3 months
Secondary	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.
Secondary	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
Secondary	Heart failure hospitalisation	Any heart failure related hospitalisations after the index procedure	30 days, 1 year