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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Trileaflet Reconstruction of the Aortic Valve
Biological Prosthesis, Device: St. Jude Medical Trifecta GT
Department of Cardiovascular Surgery, German Heart Center Munich
Munich, Bavaria, Germany
RECRUITINGEffective 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
Time frame: 10th postoperative day +/- 4 days
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
Time frame: after 6 months, 1 year and thereafter annually until the 10th postoperative year
Maximum and mean aortic pressure gradients
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Estimation of aortic regurgitation, if applicable
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular ejection fraction
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular endsystolic and -diastolic diameter
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left ventricular endsystolic and -diastolic volume
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Left atrial diameter
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Time frame: 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
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year
Freedom from Mortality
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Stroke
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Myocardial infarction
Time frame: 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
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Endocarditis
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.
Freedom from Bleeding requiring re-thoracotomy
Time frame: 10th postoperative day +/- 4 days, after 6 months, 1 year and thereafter annually until the 10th postoperative year.