Reconstruction of the aortic valve using a tri-leaflet technique
Official title: TriRec - Trileaflet Reconstruction of the Aortic Valve
Run by Deutsches Herzzentrum Muenchen · NCT03600662 · Data updated 2026-11-12
This study tests a new way to fix the aortic valve using the patient's own tissue to see if it works as well as the standard valve replacement for people over 50 with severe valve problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Deutsches Herzzentrum Muenchen Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Status | Recruiting |
| Started | January 18, 2018 |
| Main results expected | January 2020 |
| Study ends | January 2030 |
| Registry record updated | July 26, 2018 |
| Trial ID | NCT03600662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 50 and older with symptomatic moderate or greater aortic stenosis or severe aortic insufficiency.
✕Probably not a fit
Patients with recent neurological events, active infections, or those requiring concomitant cardiac procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a tri-leaflet reconstruction technique for the aortic valve, comparing it to the standard surgical aortic valve replacement using a biological prosthesis. The goal is to determine if this new approach is non-inferior in terms of effective orifice area, which is crucial for valve function. Eligible participants are those with symptomatic aortic stenosis or severe insufficiency, aged 50 and older. The intervention involves reconstructing the valve using the patient's own pericardium.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive alternative to traditional aortic valve replacement, potentially improving patient outcomes.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in valve reconstruction techniques, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 50 years * Documented symptomatic moderate or greater aortic stenosis or severe insufficiency * Aortic annulus \> 19 mm * Written informed consent of the patient. Exclusion Criteria: * Concomitant intervention of the aortic root * Concomitant intervention of the aortic arch * Concomitant valve surgery * Emergency surgery for any reason * Neurological events (i.e. stroke, TIA) within 6 months preoperatively * Coagulation disorders (including thrombocytopenia \< 100.000/ml) * Porcelain aorta * Active endocarditis or other active systemic infections * Participating in another trial that may influence the outcome of this trial * Pregnancy * Dual antiplatelet therapy * Previous cardiac surgery (excluding percutaneous procedures)
Where it's running
-
Department of Cardiovascular Surgery, German Heart Center Munich
Munich, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Markus Krane, MD, PhD
- Email: krane@dhm.mhn.de
- Phone: +4989-1218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.