Assessing early discharge after heart valve repair procedures
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety
This study is testing if older adults with heart valve issues can safely go home sooner after a specific heart repair procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oxford University Hospitals NHS Trust Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06343363 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the feasibility and safety of an early discharge protocol for patients undergoing transcatheter edge-to-edge repair (TEER) for mitral and tricuspid regurgitation. It focuses on older adults who are at high risk for surgical interventions and aims to reduce hospital stay while maintaining patient safety. The study will assess patients accepted by the Heart Team for TEER and monitor their outcomes post-procedure. The approach is based on the standard of care in Oxford, which emphasizes fewer pre-procedure investigations and shorter hospital stays.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe mitral or tricuspid regurgitation who are accepted for TEER.
Not a fit: Patients with contraindications for TEER or those with concurrent medical conditions that significantly limit life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more efficient discharge protocols for patients undergoing heart valve repair, improving their quality of life.
How similar studies have performed: Other studies have shown promising results with early discharge protocols in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oxford, Oxfordshire
- John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sam Dawkins, MBBS MRCP BSc DPhil — Oxford University Hospitals NHS Trust
- Study coordinator: Sam Dawkins, MBBS MRCP BSc DPhil
- Email: Sam.Dawkins@ouh.nhs.uk
- Phone: +443003047777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.