NCT06343363Completed
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 127 (actual)
- First submitted
- 29 Oct 2023
- Start date
- May 2023
- Primary completion date
- Feb 2025
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Diseases
- Heart failure
- NCT number
- NCT06343363
What you commit to
- Study type: Observational
- Participants enrolled: 127
- From May 2023 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
Other
- 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
- Patients requiring emergency TEER
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.