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Vascular Closure Device in Transcatheter Aortic Valve Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392492
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Magnus Dalén, Karolinska University Hospital

Brief Summary:
We evaluated 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.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: MANTA vascular closure device

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Vascular complications [ Time Frame: 6 week follow up ]
    Major and minor vascular access site complications according to the VARC-2 definitions


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 6 week follow up ]
    Bleeding complications according to the BARC definitions



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients undergoing TAVI at the Karolinska University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392492


Contacts
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Contact: Magnus Dalén, MD, PhD 08-51700000 magnus.dalen@sll.se

Locations
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Sweden
Department of Cardiology, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Magnus Dalén, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital

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Responsible Party: Magnus Dalén, Associate professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04392492    
Other Study ID Numbers: MANTA TAVI
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction