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Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

This study has been completed.
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: March 22, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 Marcie G. Berger, MD, Medical College of Wisconsin:

Primary Outcome Measures:
  • 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.

  • Pulmonary Vein Reconnection [ Time Frame: Pulmonary vein reconnection will be measured 5 minutes post second dose of adenosine, or on average 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.


Secondary Outcome Measures:
  • AF Recurrence [ Time Frame: Assess at follow-up visits 1,3,6, 12 months post ablation ]
    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 ]
    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.


Enrollment: 20
Study Start Date: May 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Wisconsin
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Marcie G Berger, MD Medical College of Wisconsin
  More Information

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
Results First Received: February 1, 2017
Last Updated: March 22, 2017

Keywords provided by Marcie G. Berger, MD, 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
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017