Trial Outcomes & Findings for HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) (NCT NCT01456000)
NCT ID: NCT01456000
Last Updated: 2016-09-08
Results Overview
Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.
COMPLETED
PHASE3
405 participants
1 year
2016-09-08
Participant Flow
There were 405 participants enrolled in the study. Thirty nine of these participants were enrolled in the run-in phase and are not reported in the pivotal data. Of the remaining 366 enrolled participants, 13 were excluded from the study prior to randomization, resulting in a total of 353 randomized participants.
Participant milestones
| Measure |
EAS-AC (HeartLight)
Treatment with the EAS-AC.
EAS-AC (HeartLight): Pulmonary vien isolation
ITT Population 178 participants
|
Control Arm Ablation
Treatment with standard ablation.
Control Arm Ablation: Treatment with standard ablation.
ITT Population 175 Participants
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
175
|
|
Overall Study
COMPLETED
|
170
|
172
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Baseline characteristics by cohort
| Measure |
EAS-AC (HeartLight)
n=170 Participants
Treatment with the EAS-AC. Randomized and treated cohort.
EAS-AC (HeartLight): Pulmonary vien isolation
|
Control Arm Ablation
n=172 Participants
Treatment with standard ablation. Randomized and treated cohort.
Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation.
|
Total
n=342 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
59.7 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
60.1 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
59.9 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
170 participants
n=5 Participants
|
172 participants
n=7 Participants
|
342 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearEpisodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.
Outcome measures
| Measure |
EAS-AC (HeartLight)
n=167 Participants
Treatment with the EAS-AC and evaluable for efficacy.
EAS-AC (HeartLight): Pulmonary vien isolation
|
Control Arm Ablation
n=167 Participants
Treatment with standard ablation and evaluable for efficacy.
Control Arm Ablation: Treatment with standard ablation.
|
|---|---|---|
|
Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description
|
102 Successful Participants
|
103 Successful Participants
|
Adverse Events
EAS-AC (HeartLight)
Control Arm Ablation
Serious adverse events
| Measure |
EAS-AC (HeartLight)
n=170 participants at risk
Treatment with the EAS-AC.
EAS-AC (HeartLight): Pulmonary vien isolation
ITT Population 178 participants
|
Control Arm Ablation
n=172 participants at risk
Treatment with standard ablation.
Control Arm Ablation: Treatment with standard ablation.
ITT Population 175 Participants
|
|---|---|---|
|
Cardiac disorders
Cardiac perforation, pericardial effusion or tamponade
|
1.8%
3/170 • Number of events 3 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
2.3%
4/172 • Number of events 4 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Nervous system disorders
CVA or stroke
|
0.59%
1/170 • Number of events 1 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
0.58%
1/172 • Number of events 1 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Cardiac disorders
Chest pain or pericarditis
|
1.2%
2/170 • Number of events 2 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
2.3%
4/172 • Number of events 4 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Musculoskeletal and connective tissue disorders
Diaphragmatic paralysis or phrenic nerve injury
|
2.9%
5/170 • Number of events 5 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
0.00%
0/172 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Vascular disorders
Hemorrhage or pseudoaneurysm
|
1.2%
2/170 • Number of events 2 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
0.00%
0/172 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Cardiac disorders
Other
|
1.8%
3/170 • Number of events 3 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
0.58%
1/172 • Number of events 1 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
Other adverse events
| Measure |
EAS-AC (HeartLight)
n=170 participants at risk
Treatment with the EAS-AC.
EAS-AC (HeartLight): Pulmonary vien isolation
ITT Population 178 participants
|
Control Arm Ablation
n=172 participants at risk
Treatment with standard ablation.
Control Arm Ablation: Treatment with standard ablation.
ITT Population 175 Participants
|
|---|---|---|
|
Cardiac disorders
Cardioversion
|
8.2%
14/170 • Number of events 14 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
9.3%
16/172 • Number of events 16 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Cardiac disorders
Chest pain/discomfort
|
2.9%
5/170 • Number of events 5 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
6.4%
11/172 • Number of events 11 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Cardiac disorders
Pericardial effusion
|
4.7%
8/170 • Number of events 8 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
8.1%
14/172 • Number of events 14 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
|
Cardiac disorders
Other
|
38.2%
65/170 • Number of events 65 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
37.2%
64/172 • Number of events 64 • 1 year
Adverse event data were collected from the time of ablation (day 0) through 1 year of follow-up
|
Additional Information
Burke Barrett, VP Regulatory & Clinical Affairs
CardioFocus, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place