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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

April 30, 2012
November 25, 2013
May 2012
May 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01590875 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Atrial Fibrillation
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.
  • 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.
    Intervention: Drug: Adenosine arm
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Marcie G Berger, MD 414-456-6777 mgberger@mcw.edu
Contact: Jason Rubenstein, MD 414-456-6777 jrubenstein@mcw.edu
United States
 
NCT01590875
MCWPRO00016186
No
Marcie G. Berger, MD, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: Marcie G Berger, MD Medical College of Wisconsin
Medical College of Wisconsin
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP