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

NCT03811119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-03-29

No results posted yet for this study

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

Interventions

DEVICE

MANTA vascular closure device

Collagen based vascular closure device

DEVICE

Suture based vascular closure device

Suture based vascular closure device (ProGlide)

Sponsors & Collaborators

Principal Investigators

  • Nicolas M Van Mieghem, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2020-02-01
Completion
2020-04-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811119 on ClinicalTrials.gov