Atrial Fibrillation
Conditions
Keywords
AF, PAF, paroxysmal atrial fibrillation, ablation, failed drugs
Brief summary
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are: * A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter * Standard drug therapy (antiarrhythmic drugs) To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you. Eligibility Criteria Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include: * 18 to 80 years of age * Frequent episodes of AF * Failed at least 1 drug treatment for AF (beta-blockers or standard AADs) * Other criteria
Interventions
DEVICEEndoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
DRUGStandard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.
Sponsors
CardioFocus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 80 years old * Paroxysmal atrial fibrillation (AF) * Frequent episodes of AF * Failed at least 1 drug treatment * Others
Exclusion criteria
* Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom for Symptomatic Episode of Atrial Fibrillation at One Year | One Year |
Countries
United States
Participant flow
Recruitment details
The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.
Pre-assignment details
None outside of the protocol.
Participants by arm
| Arm | Count |
|---|---|
| Single Ablation Procedure With Endoscopic Ablation System Single ablation procedure with Endoscopic Ablation System | 32 |
| Standard Anti-arrhythmic Drug Therapy Medication as prescribed by physician. | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Single Ablation Procedure With Endoscopic Ablation System | Standard Anti-arrhythmic Drug Therapy | Total |
|---|---|---|---|
| Age, Customized Greater than or equal to 18 Years | 32 Participants | 32 Participants | 64 Participants |
| Age, Customized Less than 18 Years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 32 participants | 32 participants | 64 participants |
| Sex/Gender, Customized Female | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Unknown | 32 Participants | 32 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 32 | 5 / 32 |
| serious Total, serious adverse events | 5 / 32 | 0 / 32 |
Outcome results
Primary
Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
Time frame: One Year
Population: Early study termination before one year.