Minimally-invasive heart valve surgery using new cannulation techniques
PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry
This study is testing new ways to insert tools during heart valve surgery to see if they can make the procedure safer and help patients recover faster compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT05961150 on ClinicalTrials.gov |
What this trial studies
The PROMISE registry investigates the safety, feasibility, and effectiveness of percutaneous cannulation methods using novel endovascular closure devices during minimally-invasive heart valve surgery. This observational study will analyze data from patients undergoing this procedure across six high-volume heart valve centers in Germany. By comparing outcomes with traditional surgical methods, the study aims to provide insights into reducing complications and improving recovery times associated with heart valve surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing minimally-invasive heart valve surgery who are treated with novel endovascular closure devices.
Not a fit: Patients who are not undergoing minimally-invasive heart valve surgery or those who do not qualify for the use of endovascular closure devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective minimally-invasive heart valve surgeries with reduced recovery times for patients.
How similar studies have performed: Other studies have shown promising results with minimally-invasive techniques in heart valve surgery, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Retrospective analysis of all patients undergoing minimally-invasive heart valve surgery using novel endovascular closure devices for percutaneous cannulation within 6 high-volume heart valve centres in Germany. Exclusion Criteria: * none
Where this trial is running
Hamburg
- University Heart and Vascular Center Hamburg, University Medical Centre Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Jonas Pausch, MD
- Email: j.pausch@uke.de
- Phone: +49 40 7410 0
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.