Comparison of a collagen-based and a suture-based vascular closure device for the occlusion of large-lumen arterial punctures during transfemoral TAVI procedures

Not Applicable

• Conditions: I35.0; I35; Aortic (valve) stenosis; Nonrheumatic aortic valve disorders

• Registration Number: DRKS00026706
• Lead Sponsor: Medizinische Klinik III, Kardiologie Universitätsklinikum Frankfurt am Main, Goethe-Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 350

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

- 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint of major and minor vascular complications according to VARC-2<br>(timeframe: periprocedural between TAVI and discharge from the hospital)

Secondary Outcome Measures

Name	Time	Method
umber of patients with minor vascular complications after VARC-2<br><br>Number of patients with major vascular complications after VARC-2<br><br>Number of patients with major and life-threatening bleeding according to VARC-2<br><br>Number of blood products transfused due to a peripheral vascular complication<br><br>Number of patients with failure of the closure device<br><br>Number of patients with clinically relevant bleeding defined according to BARC 2, 3 and 5 [16]<br><br>All-cause mortality (sub-analysis for cardiac, non-cardiac vascular death, non-cardiovascular death)