Paroxysmal Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, PAF
Brief summary
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
Interventions
DEVICECardioFocus HeartLight Endoscopic Ablation System
PVI ablation
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
* 18 to 70 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 |
|---|---|---|
| Freedom From Recurrence of Atrial Fibrillation | 12 months | Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With HeartLight Treatment of PAF with HeartLight System PVI ablation | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet all criteria-not treated | 14 |
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Treatment With HeartLight |
|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 10.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 79 Participants |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 86 |
| serious Total, serious adverse events | 14 / 86 |
Outcome results
Primary
Freedom From Recurrence of Atrial Fibrillation
Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
Time frame: 12 months
Population: Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With HeartLight | Freedom From Recurrence of Atrial Fibrillation | 50 successful participants |