Improving quality of life after heart valve replacement
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
This study looks at how people feel and do after getting a heart valve replacement to see if there are patterns that could help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 5 sites (Jerusalem and 4 other locations) |
| Trial ID | NCT02023060 on ClinicalTrials.gov |
What this trial studies
This observational study aims to track patient characteristics and outcomes following transcatheter heart valve replacement for aortic or mitral valve conditions. By collecting data over time, the study seeks to identify trends that may inform future treatment approaches. Participants will be those selected for the procedure and who provide informed consent. The study does not involve any specific interventions beyond observation.
Who should consider this trial
Good fit: Ideal candidates include patients selected for transcatheter heart valve replacement who can provide informed consent.
Not a fit: Patients who are unable to provide informed consent or are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient outcomes and improve quality of life for individuals undergoing heart valve replacement.
How similar studies have performed: Other observational studies have shown success in tracking patient outcomes in similar heart valve replacement procedures, suggesting that this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject selected for transcatheter heart valve replacement 2. Signed informed consent to participate in the study Exclusion Criteria: 1. Inability to sign written informed consent. 2. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
Where this trial is running
Jerusalem and 4 other locations
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
- Shaarei Zedek amedical Center — Jerusalem, Israel (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel Aviv Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Israel Barbash, MD
- Phone: +97235305273
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.