Medical and economic implications of free bioprosthesis in aortic valve position

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011049

Enrollment

Registered

2016-09-26

Start date

2016-06-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I35.0

Interventions

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 replace

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Germany

Contacts

Public ContactIrene Guthoff

Klinik für Herz-, Thorax- und Gefäßchirurgie

irene.guthoff@uniklinik-ulm.de0731-5000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026