TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

Not Applicable

Recruiting

• Conditions: Alternative Surgical Treatment for Aortic Valve Disease

• Registration Number: NCT03600662
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Study First Submitted: 2018-05-30
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-16
• Last Update Submitted: 2018-07-16
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Primary Completion: 2020-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effective orifice area	10th postoperative day +/- 4 days	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

Secondary Outcome Measures

Name	Time	Method
Effective orifice area	after 6 months, 1 year and thereafter annually until the 10th postoperative year	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
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.

Trial Locations

Locations (1)

Department of Cardiovascular Surgery, German Heart Center Munich; 🇩🇪 Munich, Bayern, Germany