Trial Outcomes & Findings for Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation (NCT NCT01590875)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

5 minutes post infusion first dose adenosine

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenosine Arm n=10 Participants 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 n=10 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adenosine Arm n=10 Participants 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 n=10 Participants 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.
Pulmonary Vein Reconnection	10 Participants	10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Adenosine Arm n=10 Participants 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 n=10 Participants 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.
Pulmonary Vein Reconnection Patients with PV reconnection	3 Participants	0 Participants
Pulmonary Vein Reconnection Patients without PV reconnection	7 Participants	10 Participants

Adverse Events

Adenosine Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcie Berger, MD

Medical College of Wisconsin

Phone: 414-955-6806

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place