Safe Use of New Oral Anticoagulants in Ablation for Atrial Fibrillation

NCT ID: NCT02569255

Last Updated: 2015-10-06

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

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-06-30

Brief Summary

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Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.

Detailed Description

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Use of new oral anticoagulants (NOAC) in patients before and after radiofrequency ablation with pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients paused their NOAC treatment for 24 hours before ablation. Patients were routinely followed up after 3 months with a standard formular focused on possible adverse events (major bleeding complications or thromboembolic events) to NOAC treatment. Adverse events related to the use of NOAC were registered during treatment or during 3 months of follow-up.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pulmonary venous ostia isolation

Percutaneous, catheterbased, radiofrequency ablation with left atrial access via atrial septal puncture. Helped by 3D-imaging system (Carto(tm)) and electrical signal guidance the PV ostia together with neighbouring atrial tissue is electrically isolated from the rest of the left atrium.

Intervention Type PROCEDURE

Other Intervention Names

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catheter ablation, PVI

Eligibility Criteria

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Inclusion Criteria

* Symptomatic atrial fibrillation despite pharmacological treatment.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Private Hospital Heart Center Varde

OTHER

Sponsor Role lead

Responsible Party

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Peter Steen Hansen

Chief Electrophysiologist, MD, Ph.D., DMSci

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter S Hansen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Varde Heart Center

Other Identifiers

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NOAC and PVI 2015

Identifier Type: -

Identifier Source: org_study_id

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