Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation

NCT ID: NCT02626871

Last Updated: 2017-05-04

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

COMPLETED

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2015-12-31

Brief Summary

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The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.

Detailed Description

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Conditions

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Atrial Fibrillation Stroke Transient Ischemic Attack Bleeding Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing aortic valve bioprosthesis implantation

Exclusion Criteria

* mechanical heart valves in any position
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Tuomas Kiviniemi

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuomas Kiviniemi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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Bjorn R, Lehto J, Malmberg M, Anttila V, Airaksinen KEJ, Gunn J, Kiviniemi T. Antithrombotic Medication and Major Complications After Mechanical Aortic Valve Replacement. Am J Cardiol. 2023 Oct 1;204:185-194. doi: 10.1016/j.amjcard.2023.07.097. Epub 2023 Aug 4.

Reference Type DERIVED
PMID: 37544143 (View on PubMed)

Salmi SJ, Nieminen T, Hartikainen J, Biancari F, Lehto J, Nissinen M, Malmberg M, Yannopoulos F, Savolainen J, Airaksinen J, Kiviniemi T. Indications and predictors for pacemaker implantation after isolated aortic valve replacement with bioprostheses: the CAREAVR study. Interact Cardiovasc Thorac Surg. 2020 Sep 1;31(3):398-404. doi: 10.1093/icvts/ivaa119.

Reference Type DERIVED
PMID: 32747953 (View on PubMed)

Other Identifiers

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T39/2015

Identifier Type: -

Identifier Source: org_study_id

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