Trial Outcomes & Findings for Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF (NCT NCT00958165)
NCT ID: NCT00958165
Last Updated: 2016-08-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
81 participants
Primary outcome timeframe
12 months
Results posted on
2016-08-30
Participant Flow
Participant milestones
| Measure |
EAS-AC
PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
Treated
|
72
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
EAS-AC
PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Not eligible
|
9
|
Baseline Characteristics
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Baseline characteristics by cohort
| Measure |
EAS-AC
n=72 Participants
PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
72 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.
Outcome measures
| Measure |
EAS-AC
n=67 Participants
Pulmonary vein isolation treatment with EAS-AC for PAF
|
|---|---|
|
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
|
Adverse Events
EAS-AC
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EAS-AC
n=72 participants at risk
PVI with EAS-AC
CardioFocus EAS-AC: PVI for PAF
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Phrenic nerve injury
|
1.4%
1/72 • Number of events 1
|
|
Cardiac disorders
Air embolism
|
2.8%
2/72 • Number of events 2
|
|
Cardiac disorders
Pericardial tamponade
|
5.6%
4/72 • Number of events 4
|
|
Cardiac disorders
Pericardial effusion
|
4.2%
3/72 • Number of events 3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place