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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
Results First Received: February 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Diagnostic
Condition: Atrial Fibrillation
Intervention: Drug: Adenosine arm

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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.

Participant Flow:   Overall Study
    Adenosine Arm   Observation Arm
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.
Total Total of all reporting groups

Baseline Measures
   Adenosine Arm   Observation Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6  60.0%      5  50.0%      11  55.0% 
>=65 years      4  40.0%      5  50.0%      9  45.0% 
Age 
[Units: Years]
Mean (Full Range)
 60 
 (50 to 70) 
 60 
 (55 to 70) 
 60 
 (50 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      10 100.0%      10 100.0%      20 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pulmonary Vein Reconnection   [ Time Frame: 5 minutes post infusion first dose adenosine ]

2.  Primary:   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. ]

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

4.  Secondary:   Adverse Effects Atrial Fibrillation Ablation   [ Time Frame: Assess at follow-up visits 1,3 6,12 months post ablation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marcie Berger, MD
Organization: Medical College of Wisconsin
phone: 414-955-6806
e-mail: mgberger@mcw.edu



Responsible Party: Marcie G. Berger, MD, 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