Trial Outcomes & Findings for Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial) (NCT NCT01932112)

Results Overview

After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

378 participants

Primary outcome timeframe

5 minutes after IV adenosine

Results posted on

2017-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Adenosine Arm After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. Adenosine arm: After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Overall Study STARTED	378
Overall Study COMPLETED	378
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adenosine Arm n=378 Participants After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants
Region of Enrollment Korea, Republic of	378 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes after IV adenosine

After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Outcome measures

Outcome measures
Measure	Adenosine Arm n=378 Participants After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion	92 participants

SECONDARY outcome

Timeframe: between 0 and 12 months

At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)

Outcome measures

Outcome data not reported

Adverse Events

Adenosine Arm

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adenosine Arm n=378 participants at risk After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Respiratory, thoracic and mediastinal disorders cough	0.53% 2/378 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Y. Oh, director of clinical trial

Seoul St Mary's hospital

Phone: 82-2-2258-1141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place