Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

NCT ID: NCT01724437

Last Updated: 2022-09-01

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

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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to assess the near-term (12 months) efficacy of pulmonary vein isolation.

Detailed Description

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The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Conditions

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Paroxysmal Atrial Fibrillation Catheter Ablation Strategies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Loss of pace capture

Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved

catheter based pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

catheter based pulmonary vein isolation

Intervention Type DEVICE

catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

Conventional

Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.

catheter based pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

catheter based pulmonary vein isolation

Intervention Type DEVICE

catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

Interventions

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catheter based pulmonary vein isolation

catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* written informed consent
* age \> 18 years
* paroxysmal atrial fibrillation

Exclusion Criteria

* structural heart disease
* intracardiac thrombus
* reversible causes of atrial fibrillation
* inability to take warfarin
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Willems

Role: PRINCIPAL_INVESTIGATOR

Universitäres Herzzentrum Hamburg GmbH

Locations

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University Hospital Hamburg

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.

Reference Type DERIVED
PMID: 23644091 (View on PubMed)

Other Identifiers

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PV3503

Identifier Type: -

Identifier Source: org_study_id

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