Vascular Closure Device in Transcatheter Aortic Valve Replacement

November 30, 2020 updated by: Magnus Dalén, Karolinska University Hospital

Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement

Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Department of Cardiology, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undergoing TAVI at the Karolinska University Hospital

Description

Inclusion Criteria:

  • Patients undergoing transfemoral TAVI at the Karolinska University Hospital

Exclusion Criteria:

  • Patients undergoing TAVI with access other than transfemoral
  • Use of closure device other than MANTA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing transfemoral TAVI with MANTA closure
Patients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA).
Device: MANTA vascular closure device
Femoral access site closure using the MANTA closure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with major vascular complications
Time Frame: 6 week follow up
Major vascular access site complications according to the VARC-2 definitions
6 week follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with minor vascular complications
Time Frame: 6 week follow up
Minor vascular access site complications according to the VARC-2 definitions
6 week follow up
Number of patients with vascular closure device failure
Time Frame: 6 week follow up
Percutaneous vascular closure device failure according to the VARC-2 definitions
6 week follow up
Number of patients with life-threatening, disabling or major bleeding
Time Frame: 6 week follow up
Life-threatening, disabling or major bleeding complications according to the BARC definitions
6 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANTA TAVI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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