Clinical trial NCT03811119: Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Official title: MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Vascular Closure Devices
Transcatheter Aortic Valve Implantation
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized trial
Primary purpose: TREATMENT

Brief summary: To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.

Detailed description: see summary

Eligibility criteria: 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 (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

Primary outcomes:
measure: Composite rate of major- and minor vascular complications according to VARC-2
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
Secondary outcomes:
measure: Number of Participants with a Major Vascular Complication according to VARC-2
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: Number of Participants with a Minor Vascular Complication according to VARC-2
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: All-cause death rate
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: Number of Participants with a major- or life threatening bleeding according to VARC-2
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: Need for transfusions for access site related bleeding/complications
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: Number of Participants with vascular closure device failure
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: Time to hemostasis
timeFrame: During the TAVI procedure
measure: Total procedure time
timeFrame: During the TAVI procedure
measure: Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5
timeFrame: Between transcatheter aortic valve implantation and 30 days follow-up
measure: Length of hospital stay
timeFrame: Up to a maximum of 30 days after the TAVI procedure
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center Rotterdam
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas M Van Mieghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: