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Vascular Closure Device in Transcatheter Aortic Valve Replacement

NCT ID: NCT04392492

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-25

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

MANTA vascular closure device

Intervention Type DEVICE

Femoral access site closure using the MANTA closure device

Interventions

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MANTA vascular closure device

Femoral access site closure using the MANTA closure device

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Dalén

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 35427700 (View on PubMed)

Other Identifiers

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MANTA TAVI

Identifier Type: -

Identifier Source: org_study_id