Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Marcie G. Berger, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01590875
First received: April 30, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Drug: Adenosine arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of the Durability of the Adenosine Effect in Verification of Pulmonary Vein Isolation

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Pulmonary vein reconnection [ Time Frame: 5 minutes post infusion first dose adenosine ] [ Designated as safety issue: No ]
    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.

  • Pulmonary vein reconnection [ Time Frame: 5 minutes post second dose of adenosine ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • AF recurrence [ Time Frame: Assess at follow-up visits 1,3,6, 12 months post ablation ] [ Designated as safety issue: No ]
    At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform chart review to evaluate for adverse effects of procedure and or adenosine administration and AF recurrence.

  • Adverse effects atrial fibrillation ablation [ Time Frame: Assess at follow-up visits 1,3 6,12 months post ablation ] [ Designated as safety issue: Yes ]
    At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform chart review to evaluate for adverse effects of procedure and or adenosine administration.


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590875

Contacts
Contact: Marcie G Berger, MD 414-456-6777 mgberger@mcw.edu
Contact: Jason Rubenstein, MD 414-456-6777 jrubenstein@mcw.edu

Locations
United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Marcie G Berger, MD    414-805-6204    mgberger@mcw.edu   
Principal Investigator: Marcie G Berger, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Marcie G Berger, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Marcie G. Berger, MD, PI, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01590875     History of Changes
Other Study ID Numbers: MCWPRO00016186
Study First Received: April 30, 2012
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
atrial fibrillation
ablation
pulmonary veins
adenosine

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014