TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

Study Overview
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Brief Summary
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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.

Official Title
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TriRec - Trileaflet Reconstruction of the Aortic Valve

Conditions
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Alternative Surgical Treatment for Aortic Valve Disease

Intervention / Treatment
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* Other: TriRec
* Other: Aortic valve replacement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TriRec<br>Trileaflet Reconstruction of the Aortic Valve | Other: TriRec<br>* Trileaflet Reconstruction of the Aortic Valve<br>|
| Experimental: Aortic valve replacement<br>Biological prosthesis, Device: St. Jude Medical Trifecta GT | Other: Aortic valve replacement<br>* Biological Prosthesis, Device: St. Jude Medical Trifecta GT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective orifice area | Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography | 10th postoperative day +/- 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective orifice area | Effective orifice area in cm2 (EOA) either after the TriRec- procedure or surgical valve replacement with the St. Jude Medical Trifecta GT Valve, measured by echocardiography | after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Maximum and mean aortic pressure gradients |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 
| Estimation of aortic regurgitation, if applicable |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Left ventricular ejection fraction |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Left ventricular endsystolic and -diastolic diameter |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Left ventricular endsystolic and -diastolic volume |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Left atrial diameter |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Freedom from aortic valve reintervention at discharge |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year | 
| Freedom from Mortality |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 
| Freedom from Stroke |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 
| Freedom from Myocardial infarction |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 
| Freedom from conduction disturbances leading to permanent pacemaker implantation |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 
| Freedom from Endocarditis |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 
| Freedom from Bleeding requiring re-thoracotomy |  | 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, Effective orifice area