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Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

NCT ID: NCT01590875

Last Updated: 2017-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-06-30

Brief Summary

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Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

Detailed Description

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Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.

Conditions

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Atrial Fibrillation

Keywords

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atrial fibrillation ablation pulmonary veins adenosine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adenosine arm

25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.

Group Type EXPERIMENTAL

Adenosine arm

Intervention Type DRUG

In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.

Observation arm

25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adenosine arm

In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications

Exclusion Criteria

* allergy or contraindication to adenosine,
* inability to give informed consent,
* currently taking dipyridamole,
* verapamil or theophylline and
* breast-feeding mothers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Marcie G. Berger, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcie G Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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MCWPRO00016186

Identifier Type: -

Identifier Source: org_study_id