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Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590875
First Posted: May 3, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcie G. Berger, MD, Medical College of Wisconsin
April 30, 2012
May 3, 2012
February 1, 2017
May 3, 2017
November 6, 2017
May 2012
June 2015   (Final data collection date for primary outcome measure)
  • 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.
  • 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 [ 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: 5 minutes post second dose of 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, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection.
Complete list of historical versions of study NCT01590875 on ClinicalTrials.gov Archive Site
Not Provided
  • 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.
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
20
June 2015
June 2015   (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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01590875
MCWPRO00016186
No
Not Provided
Not Provided
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
October 2017

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