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Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

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ClinicalTrials.gov Identifier: NCT01590875
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : May 3, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Marcie G. Berger, MD, Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Atrial Fibrillation
Intervention Drug: Adenosine arm
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adenosine Arm Observation Arm
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Adenosine Arm Observation Arm Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 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, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
60
(50 to 70)
60
(55 to 70)
60
(50 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
20
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Pulmonary Vein Reconnection
Hide Description 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.
Time Frame 5 minutes post infusion first dose adenosine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine Arm Observation Arm
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine Arm
Comments Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose
Type of Statistical Test Equivalence
Comments Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method no relevant statistical analysis
Comments [Not Specified]
2.Primary Outcome
Title Pulmonary Vein Reconnection
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adenosine Arm Observation Arm
Hide Arm/Group Description:

10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given only if no reconnection after initial dose.

Of these 10 patients, 3 patients were noted to have pulmonary vein reconnection post initial dose of adenosine in at least one pulmonary vein. No patient demonstrated pulmonary vein reconnection with second dose of adenosine.

10 patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.

Of these 10 patients, none demonstrated pulmonary vein reconnection during the 10 minute period of observation.

Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with PV reconnection
3
  30.0%
0
   0.0%
Patients without PV reconnection
7
  70.0%
10
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adenosine Arm
Comments Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose
Type of Statistical Test Equivalence
Comments Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose
Statistical Test of Hypothesis P-Value < 0.01
Comments [Not Specified]
Method kappa statistic
Comments [Not Specified]
Time Frame Adenosine the drug administered in the study is short acting with half life of less than 10 seconds. Adverse event data was collected from the time of the first adenosine administration to 30 minutes after the final adenosine administration. Thus total time over which adverse event data were collected was approximately 45 minutes.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adenosine Arm Observation Arm
Hide Arm/Group Description 10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without reconnection after initial dose. 10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
All-Cause Mortality
Adenosine Arm Observation Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adenosine Arm Observation Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adenosine Arm Observation Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Marcie Berger, MD
Organization: Medical College of Wisconsin
Phone: 414-955-6806
EMail: mgberger@mcw.edu
Layout table for additonal information
Responsible Party: Marcie G. Berger, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01590875     History of Changes
Other Study ID Numbers: MCWPRO00016186
First Submitted: April 30, 2012
First Posted: May 3, 2012
Results First Submitted: February 1, 2017
Results First Posted: May 3, 2017
Last Update Posted: November 6, 2017