Paroxysmal Atrial Fibrillation
Conditions
Keywords
Treatment of PAF using EAS-AC
Brief summary
The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).
Interventions
DEVICECardioFocus EAS-AC
PVI for PAF
Sponsors
CardioFocus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic, Paroxysmal atrial fibrillation (AF) * 18 to 70 years of age * Failure of at least one AAD * Others
Exclusion criteria
* Generally good overall health as determined by multiple criteria * Willing to participate in a study * Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. | 12 months |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EAS-AC PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Not eligible | 9 |
Baseline characteristics
| Characteristic | EAS-AC |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10 |
| Region of Enrollment Germany | 72 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 72 |
| serious Total, serious adverse events | 10 / 72 |
Outcome results
Primary
Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.
Time frame: 12 months
Population: Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EAS-AC | Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. | 42 Successful participants |