Atrial Fibrillation
Conditions
Keywords
Arrhythmia, Atrial Fibrillation
Brief summary
The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).
Interventions
DEVICEEpicor LP Cardiac Ablation System
Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery
PROCEDURESurgical ablation of permanent AF
Concomitant AF ablation during mitral valve surgery
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old * Permanent AF defined as continuous AF lasting \> one year OR non self-terminating AF lasting \> seven days but no more than one year with at least one failed DC cardioversion * Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery * Be able to take anticoagulation therapy * Be able to fulfill study requirements * Be able to sign study-specific informed consent
Exclusion criteria
* Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy * Prior cardiac surgery * Presence of active endocarditis, local or system infection * Presence of advanced heart failure (NYHA class \> II, & LVEF \< 20%) * Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days * Emergent cardiac surgery due to acute MI or acute mitral regurgitation * Life expectancy \< 1 year * Major or progressive non-cardiac disease * Presence of left atrial thrombi * Left atrial diameter \> 6.0 cm * Any condition that prevents investigator from safely performing procedure * Positive urine or serum pregnancy test * Prior left atrial ablation * Currently participating in another clinical research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Atrial Fibrillation in the Absence of Any AF Therapies | 6 months | Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 valve surgery | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Epicor Cardiac Ablation |
|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 112 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 112 |
| serious Total, serious adverse events | 11 / 112 |
Outcome results
Primary
Freedom From Atrial Fibrillation in the Absence of Any AF Therapies
Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epicor Cardiac Ablation | Freedom From Atrial Fibrillation in the Absence of Any AF Therapies | 49 participants |