Atrial Fibrillation, Persistent Common Pulmonary Vein
Conditions
Keywords
Pulmonary Vein Isolation, Adenosin effect, Atrial fibrillation ablation
Brief summary
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation
Detailed description
Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction. Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.
Interventions
DRUGAdenosine arm
After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Sponsors
Yong Seog Oh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed atrial fibrillation * recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use * written informed consent
Exclusion criteria
* intracardiac thrombus * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion | 5 minutes after IV adenosine | After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation Recurrence | 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) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adenosine Arm 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. | 378 |
| Total | 378 |
Baseline characteristics
| Characteristic | Adenosine Arm |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 11 |
| Region of Enrollment Korea, Republic of | 378 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 378 |
| serious Total, serious adverse events | 2 / 378 |
Outcome results
Primary
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Time frame: 5 minutes after IV adenosine
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adenosine Arm | Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion | 92 participants |
Secondary
Atrial Fibrillation Recurrence
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)
Time frame: between 0 and 12 months