Alternative Surgical Treatment for Aortic Valve Disease
Conditions
Keywords
aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, Effective orifice area
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.
Interventions
OTHERTriRec
Trileaflet Reconstruction of the Aortic Valve
OTHERAortic valve replacement
Biological Prosthesis, Device: St. Jude Medical Trifecta GT
Sponsors
Department of Cardiovascular Surgery, German Heart Center Munich
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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. | — |
| 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 | — |
Countries
Germany
Contacts
Primary ContactMarkus Krane, MD, PhD
Outcome results
None listed