Trial Outcomes & Findings for Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation (NCT NCT00971204)

NCT ID: NCT00971204

Last Updated: 2016-08-01

Results Overview

Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-08-01

Participant Flow

Participant milestones

Measure	Treatment With EAS-AC Treatment of PAF with EAS-AC CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation
Overall Study STARTED	100
Overall Study Treated	86
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	Treatment With EAS-AC Treatment of PAF with EAS-AC CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation
Overall Study Did not meet all criteria-not treated	14
Overall Study Lost to Follow-up	10

Baseline Characteristics

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Baseline characteristics by cohort

Measure	Treatment With HeartLight n=86 Participants Treatment of PAF with HeartLight System PVI ablation
Age, Continuous	56.7 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.

Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.

Outcome measures

Measure	Treatment With HeartLight n=84 Participants Treatment of PAF with HeartLight System CardioFocus HeartLight Endoscopic Ablation System: PVI ablation
Freedom From Recurrence of Atrial Fibrillation	50 successful participants

Adverse Events

Treatment With HeartLight

Serious events: 14 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment With HeartLight n=86 participants at risk Treatment of PAF with HeartLight
Cardiac disorders Cardiac perforation, pericardial effusion, tamponade	4.7% 4/86 • Number of events 4
Cardiac disorders Pericarditis	8.1% 7/86 • Number of events 7
Musculoskeletal and connective tissue disorders Phrenic nerve injury	5.8% 5/86 • Number of events 5
Cardiac disorders Death, unrelated to investigational device	1.2% 1/86 • Number of events 1

Other adverse events

Measure	Treatment With HeartLight n=86 participants at risk Treatment of PAF with HeartLight
Cardiac disorders Chest pain/discomfort	11.6% 10/86 • Number of events 12
Cardiac disorders Pericarditis	9.3% 8/86 • Number of events 8
Musculoskeletal and connective tissue disorders Phrenic nerve injury	5.8% 5/86 • Number of events 5

Additional Information

Burke Barrett, VP Regulatory & Clinical Affairs

CardioFocus, Inc.

Phone: 508 658-7200

Email: bbarrett@cardiofocus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place