Vascular Closure Device in Transcatheter Aortic Valve Replacement
Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2017
CompletedFirst Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedDecember 2, 2020
November 1, 2020
3.9 years
May 13, 2020
November 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with major vascular complications
Major vascular access site complications according to the VARC-2 definitions
6 week follow up
Secondary Outcomes (3)
Number of patients with minor vascular complications
6 week follow up
Number of patients with vascular closure device failure
6 week follow up
Number of patients with life-threatening, disabling or major bleeding
6 week follow up
Study Arms (1)
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).
Interventions
Femoral access site closure using the MANTA closure device
Eligibility Criteria
Consecutive patients undergoing TAVI at the Karolinska University Hospital
You may qualify if:
- Patients undergoing transfemoral TAVI at the Karolinska University Hospital
You may not qualify if:
- Patients undergoing TAVI with access other than transfemoral
- Use of closure device other than MANTA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Karolinska University Hospital
Stockholm, Sweden
Related Publications (1)
Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12.
PMID: 35427700DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
January 25, 2017
Primary Completion
December 31, 2020
Study Completion
January 31, 2021
Last Updated
December 2, 2020
Record last verified: 2020-11