Medical and economic implications of free bioprosthesis in aortic valve positio
- Conditions
- I35.0Aortic (valve) stenosis
- Registration Number
- DRKS00011049
- Lead Sponsor
- Klinik für Herz-, Thorax- und Gefäßchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Operation worthy aortic stenosis associated with coronary heart disease, which requires the installation of at least one IMA graft and a vein graft
- Aged 50 - 80 years
- Elective or urgent indication for surgery
- Technical possibility of implantation, both a seam-free as well as a conventional prosthesis
- Approval of the study after the enlightenment
- Consent to participate in a one-year follow-up
- Pure aortic insufficiency without calcifications
- Less than two target vessels for bypass surgery, or target vessels that appear to be unsuitable for an IMA graft investment
- Indication or explicit patient request for implantation of a mechanical prosthesis
- Indication or explicit patient request for implantation of a catheter-based prosthesis
- EF <30%
- Acute endocarditis
- Renal insufficiency (creatinine 2x ULN or dialysis)
- Hepatic impairment (ALT 2x ULN)
- Emergency intervention
- Not present capacity
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Medical benefit for patients, according to<br>- hemodynamics of the aortic valve prosthesis intraoperatively and after the operation<br>- operation times (total operating time, HLM-time, aortic clamping time)<br>- postoperative course<br>- hospital stay<br>- duration of ventilation<br>- length of stay in the ICU<br>- postoperative complications (bleeding amount, blood transfusion, new-onset atrial fibrillation, recent onset AV block, respiratory failure, renal failure, infections)<br>- re-hospitalization <br>- quality of life after 3 and 12 months<br><br>Economic benefit in Ulm, according to<br>-DRG revenue<br>- patient-related actual costs (material resources, personnel) <br>
- Secondary Outcome Measures
Name Time Method