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New treatment option for Alternative Surgical Treatment for Aortic Valve Disease
Official title TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
ClinicalTrials.gov ID: NCT03600662
What this study is testing
- What it's testing
- Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age \>= 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
- Aortic annulus \> 19 mm
- Written informed consent of the patient.
You likely can't join if
- 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)
See the full eligibility criteria
- Age \>= 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
- Aortic annulus \> 19 mm
- Written informed consent of the patient.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Bavaria, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Bavaria, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.