Paroxysmal Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, AF, PAF, PVI, ablation, paroxysmal atrial fibrillation, pulmonary vein isolation
Brief summary
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
Detailed description
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.
Interventions
DEVICEEAS-AC (HeartLight)
Pulmonary vien isolation
PROCEDUREControl Arm Ablation
Treatment with standard ablation.
Sponsors
CardioFocus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years. * paroxysmal atrial fibrillation * failure of at least one AAD * others
Exclusion criteria
* overall good health as established by multiple criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description | 1 year | Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure. |
Countries
United States
Participant flow
Recruitment details
There were 405 participants enrolled in the study. Thirty nine of these participants were enrolled in the run-in phase and are not reported in the pivotal data. Of the remaining 366 enrolled participants, 13 were excluded from the study prior to randomization, resulting in a total of 353 randomized participants.
Participants by arm
| Arm | Count |
|---|---|
| EAS-AC (HeartLight) Treatment with the EAS-AC. Randomized and treated cohort.
EAS-AC (HeartLight): Pulmonary vien isolation | 170 |
| Control Arm Ablation Treatment with standard ablation. Randomized and treated cohort.
Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation. | 172 |
| Total | 342 |
Baseline characteristics
| Characteristic | EAS-AC (HeartLight) | Control Arm Ablation | Total |
|---|---|---|---|
| Age, Customized Age | 59.7 Years STANDARD_DEVIATION 10.4 | 60.1 Years STANDARD_DEVIATION 8.9 | 59.9 Years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 170 participants | 172 participants | 342 participants |
| Sex: Female, Male Female | 52 Participants | 63 Participants | 115 Participants |
| Sex: Female, Male Male | 118 Participants | 109 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 170 | 105 / 172 |
| serious Total, serious adverse events | 16 / 170 | 10 / 172 |
Outcome results
Primary
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EAS-AC (HeartLight) | Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description | 102 Successful Participants |
| Control Arm Ablation | Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description | 103 Successful Participants |