Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

NCT03811119 | Completed

• 1 other identifier: MASH TAVI 06-09-2018
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Vascular Closure Devices; Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

• Composite rate of major- and minor vascular complications according to VARC-2

  The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.

  Between transcatheter aortic valve implantation and 30 days follow-up

Secondary Outcomes (10)

• Number of Participants with a Major Vascular Complication according to VARC-2

  Between transcatheter aortic valve implantation and 30 days follow-up

• Number of Participants with a Minor Vascular Complication according to VARC-2

  Between transcatheter aortic valve implantation and 30 days follow-up

• All-cause death rate

  Between transcatheter aortic valve implantation and 30 days follow-up

• Number of Participants with a major- or life threatening bleeding according to VARC-2

  Between transcatheter aortic valve implantation and 30 days follow-up

• Need for transfusions for access site related bleeding/complications

  Between transcatheter aortic valve implantation and 30 days follow-up

Study Arms (2)

MANTA vascular closure device

ACTIVE COMPARATOR

Arteriotomy closure with a collagen-based vascular closure device (MANTA™)

Device: MANTA vascular closure device

Suture based vascular closure device

ACTIVE COMPARATOR

Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)

Device: Suture based vascular closure device

Interventions

MANTA vascular closure device DEVICE

Collagen based vascular closure device

MANTA vascular closure device

Suture based vascular closure device DEVICE

Suture based vascular closure device (ProGlide)

Suture based vascular closure device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center Rotterdam

Rotterdam, 3000 CA, Netherlands

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Nicolas M Van Mieghem, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label randomized trial

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: October 30, 2018
• Primary Completion: February 1, 2020
• Study Completion: April 30, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)