Medical and economic implications of free bioprosthesis in aortic valve position

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00011049
• Date of registration: 26/09/2016
• Prospective Registration: No
• Primary sponsor: Klinik für Herz-, Thorax- und Gefäßchirurgie
• Public title: Medical and economic implications of free bioprosthesis in aortic valve position
• Scientific title: Medical and economic implications of free bioprosthesis in aortic valve position
• Date of first enrolment: 13/06/2016
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00011049
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose:
• Phase: 4

Countries of recruitment

Germany

Contacts

• Name: Irene Guthoff
• Affiliation: Klinik für Herz-, Thorax- und Gefäßchirurgie

• Name: Irene Guthoff
• Affiliation: Klinik für Herz-, Thorax- und Gefäßchirurgie

Key inclusion & exclusion criteria

Inclusion criteria: - 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
Exclusion criteria: - 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

Age minimum: 50 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

I35.0

I35.0

Aortic (valve) stenosis

Intervention(s)

Group 1: • "Intuity" (in 10 patients the aortic valve replacement is performed by balloon expandable xenograft with fixation sutures)
Group 2: Group "Perceval" (in 10 patients the aortic valve replacement is performed through self-expanding xenograft valves without fixing seams)
Group 3: • "Conventional PERIMOUNT" (in 5 patients the aortic valve replacement is performed by a Perimount Valve)
Group 4: • "Conventional Crown" (5 x AKE by xenograft (pericardial bioprosthesis)

Primary Outcome(s)

Medical benefit for patients, according to
- hemodynamics of the aortic valve prosthesis intraoperatively and after the operation
- operation times (total operating time, HLM-time, aortic clamping time)
- postoperative course
- hospital stay
- duration of ventilation
- length of stay in the ICU
- postoperative complications (bleeding amount, blood transfusion, new-onset atrial fibrillation, recent onset AV block, respiratory failure, renal failure, infections)
- re-hospitalization
- quality of life after 3 and 12 months

Economic benefit in Ulm, according to
-DRG revenue
- patient-related actual costs (material resources, personnel)

Source(s) of Monetary Support

Hier die Adresse eintragenKlinik für Herz-, Thorax- und Gefäßchirurgie

Ethics review

Status: Approved
Approval date: 14/04/2016
Contact:

[e-mail]

Ethikkommission der Universität Ulm

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00011049#studyResults