Clinical trial NCT03600662: TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium
Official title: TriRec - Trileaflet Reconstruction of the Aortic Valve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alternative Surgical Treatment for Aortic Valve Disease
Keywords: aortic stenosis
aortic regurgitation
Trileaflet reconstruction of the aortic valve
Biological aortic valve prosthesis
Effective orifice area
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Department of Cardiovascular Surgery, German Heart Center Munich
First posted: 2018-07-26
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Effective orifice area
timeFrame: 10th postoperative day +/- 4 days
Secondary outcomes:
measure: Effective orifice area
timeFrame: after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Maximum and mean aortic pressure gradients
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
measure: Estimation of aortic regurgitation, if applicable
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Left ventricular ejection fraction
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Left ventricular endsystolic and -diastolic diameter
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Left ventricular endsystolic and -diastolic volume
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Left atrial diameter
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Freedom from aortic valve reintervention at discharge
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
measure: Freedom from Mortality
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
measure: Freedom from Stroke
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
measure: Freedom from Myocardial infarction
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
measure: Freedom from conduction disturbances leading to permanent pacemaker implantation
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
measure: Freedom from Endocarditis
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
measure: Freedom from Bleeding requiring re-thoracotomy
timeFrame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Cardiovascular Surgery, German Heart Center Munich
state: Bayern
Study officials:
affiliation: Department of Cardiovascular Surgery, German Heart Center Munich
name: Markus Krane, MD, PhD
role: STUDY_CHAIR
References: