MANTA* versus suture-based closure after Transcatheter Aortic Valve Implantation Trial

Recruiting

• Conditions: injury of an artery; vascular complications; 10046973; 10047079

• Registration Number: NL-OMON48880
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)
- Common femoral artery diameter > 5.0mm (14 - 22F compatible)

Exclusion Criteria

- Symptomatic leg ischaemia
- Previous thromboendarterectomy or plastic patch of the common femoral artery
- Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months
- Unilateral or bilateral lower extremity amputation
- Systemic infection or a local infection at or near the access site
- Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel)
- Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure
- Patient unable to be adequately anti-coagulated for the procedure
- Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
- Anatomical and procedural contraindication for suture-based or Manta closure such as a lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease
- Absence of computed tomographic data of the access site before the procedure
- Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
- Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory)
- Participating in trials in which the primary endpoint includes bleeding or vascular complications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The composite of major vascular complications, and minor vascular complications<br /><br>according to VARC 2 at 30 days. </p><br>