TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

Alternative Surgical Treatment for Aortic Valve Disease Clinical Trial

— TriRec  

Official title:

TriRec - Trileaflet Reconstruction of the Aortic Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03600662
• Other study ID #: 389/17S
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: January 2030

Study information

• Verified date: July 2018
• Source: Deutsches Herzzentrum Muenchen
• Contact: Markus Krane, MD, PhD
• Phone: +4989-1218
• Email: krane[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: January 2030
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alternative Surgical Treatment for Aortic Valve Disease

Intervention

Other:
• TriRec
Trileaflet Reconstruction of the Aortic Valve
• Aortic valve replacement
Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Locations

Country	Name	City	State
Germany	Department of Cardiovascular Surgery, German Heart Center Munich	Munich	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Department of Cardiovascular Surgery, German Heart Center Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Maximum and mean aortic pressure gradients		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Secondary	Estimation of aortic regurgitation, if applicable		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Secondary	Left ventricular ejection fraction		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Secondary	Left ventricular endsystolic and -diastolic diameter		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Secondary	Left ventricular endsystolic and -diastolic volume		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Secondary	Left atrial diameter		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Secondary	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
Secondary	Freedom from Mortality		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Secondary	Freedom from Stroke		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Secondary	Freedom from Myocardial infarction		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Secondary	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.
Secondary	Freedom from Endocarditis		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Secondary	Freedom from Bleeding requiring re-thoracotomy		10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.