Trial Outcomes & Findings for CONcomitant eValuation of Epicor Left atRial Therapy for AF (NCT NCT00519194)

Results Overview

Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

6 months

Results posted on

2019-02-19

Participant milestones
Measure	Epicor Cardiac Ablation Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure
Overall Study STARTED	112
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	21

Reasons for withdrawal
Measure	Epicor Cardiac Ablation Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure
Overall Study Withdrawal by Subject	9
Overall Study Death	9
Overall Study Lost to Follow-up	3

CONcomitant eValuation of Epicor Left atRial Therapy for AF

Baseline characteristics by cohort
Measure	Epicor Cardiac Ablation n=112 Participants Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery
Age, Continuous	72.4 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants

Timeframe: 6 months

Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.

Outcome measures
Measure	Epicor Cardiac Ablation n=91 Participants Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies	49 participants

Serious events: 11 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Epicor Cardiac Ablation n=112 participants at risk Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery
Cardiac disorders Cardiac injury related to Epicor device rsulting in unplanned surgical or catheter intervention	0.89% 1/112 • Number of events 1
Cardiac disorders Death	2.7% 3/112 • Number of events 3
Cardiac disorders Myocardial infarction	0.89% 1/112 • Number of events 1
Cardiac disorders Newly developed third degree AV block requiring permanent pacemaker implantation	3.6% 4/112 • Number of events 4
Vascular disorders Peripheral arterial embolism	0.89% 1/112 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.89% 1/112 • Number of events 1

Other adverse events
Measure	Epicor Cardiac Ablation n=112 participants at risk Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery
Cardiac disorders Acute heart failure	0.89% 1/112 • Number of events 1

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