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Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

NCT04459208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2021-09-29

No results posted yet for this study

Summary

The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Manta

plug-based vascular closure

DEVICE

ProGlide

suture-based vascular closure

Sponsors & Collaborators

  • Helios Health Institute GmbH

    lead OTHER

Principal Investigators

  • Mohamed Abdel-Wahab, PD Dr. · Herzzentrum Leipzig GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2021-07-07
Completion
2021-08-04

Countries

  • Germany

Study Locations

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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 NCT04459208 on ClinicalTrials.gov