I35.0 I35
Conditions
Interventions
Group 1: closure with Manta® (Teleflex, Wayne, PA, USA)
Group 2: closure with ProGlide® (Abbott Vascular, Santa Clara, CA, USA)
Sponsors
Medizinische Klinik III, Kardiologie Universitätsklinikum Frankfurt am Main, Goethe-Universität
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - All patients> 18 years of age who receive an elective catheter-supported aortic valve replacement via a transfemoral access in the Medical Clinic III / Cardiology and / or the Clinic for Thoracic, Cardiac and Vascular Surgery at the University Hospital Frankfurt - Inguinal / pelvic vessels suitable for the introduction of large-lumen vascular sluices up to 24F. - Common femoral artery diameter> 6mm (compatible with 24F cannulas)
Exclusion criteria
Exclusion criteria: - Patients <18 years of age - Cardiogenic shock / clinically critical condition prior to intervention - Symptomatic ischemia of the lower extremity - Severe PAOD that requires a groin intervention (dilation / stent implantation) for the transfemoral percutaneous access - s/p unilateral or bilateral amputation of the lower extremity - Pregnancy (negative pregnancy test is mandatory for patients of childbearing age) - Participation in another study with the primary endpoint vascular complications / bleeding - Known allergies to components of both systems (e.g. bovine materials collagens, polyglycols, stainless steel, nickel) - Contraindication for the expected safe use of one of the locking systems Manta® or Proglide® locking system (severe calcification, aneurysm, fistula)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of major and minor vascular complications according to VARC-2 (timeframe: periprocedural between TAVI and discharge from the hospital) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with minor vascular complications after VARC-2 Number of patients with major vascular complications after VARC-2 Number of patients with major and life-threatening bleeding according to VARC-2 Number of blood products transfused due to a peripheral vascular complication Number of patients with failure of the closure device Number of patients with clinically relevant bleeding defined according to BARC 2, 3 and 5 [16] All-cause mortality (sub-analysis for cardiac, non-cardiac vascular death, non-cardiovascular death) | — |
Countries
Germany
Contacts
Public ContactMariuca Vasa-Nicotera
Medizinische Klinik III, Kardiologie Universitätsklinikum Frankfurt am Main, Goethe-Universität
Outcome results
None listed