Trial Outcomes & Findings for Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation (NCT NCT01196923)
NCT ID: NCT01196923
Last Updated: 2016-07-27
Results Overview
99% of pulmonary veins were isolated (72/73)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Acute PVI measured on the day of treatment
Results posted on
2016-07-27
Participant Flow
Participant milestones
| Measure |
HeartLight Ablation
Pulmonary Vein Isolation with the HeartLight System
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
HeartLight Ablation
n=20 Participants
Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
|
|---|---|
|
Age, Customized
Average age, reported data
|
59 years
n=5 Participants
|
|
Gender
Female
|
3 participants with data available
n=5 Participants
|
|
Gender
Male
|
16 participants with data available
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Acute PVI measured on the day of treatmentPopulation: All treated participants with reported data.
99% of pulmonary veins were isolated (72/73)
Outcome measures
| Measure |
HeartLight Acutely Isolated Pulmonary Veins
n=20 Participants
|
|---|---|
|
Acute Isolation of Pulmonary Veins.
|
99 percent isolated pulmonary veins
|
Adverse Events
HeartLight Ablation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HeartLight Ablation
n=20 participants at risk
Pulmonary Vein Isolation with the HeartLight System
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
5.0%
1/20 • Number of events 1 • Acute, peri-procedural assessment of adverse events.
|
Other adverse events
Adverse event data not reported
Additional Information
Burke Barrett, VP, Regulatory & Clinical Affairs
CardioFocus, Inc.
Phone: 508 658-7200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place