Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

October 5, 2017 updated by: Marcie G. Berger, MD, Medical College of Wisconsin

Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Vein Reconnection
Time Frame: 5 minutes post infusion first dose adenosine
In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes after adenosine administration.
5 minutes post infusion first dose adenosine
Pulmonary Vein Reconnection
Time Frame: Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.
In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein. Pulmonary vein isolation is defined as disappearance of all local intracardiac electrograms within a pulmonary vein recorded on a 10 electrode circular catheter or lasso catheter positioned within the vein.
Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Marcie G Berger, MD, Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCWPRO00016186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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