Atrial Fibrillation
Conditions
Keywords
Patients
Brief summary
While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative arrhythmia burden following surgical treatment for AF in patients undergoing either lone or concomitant heart surgery.
Interventions
DEVICEReveal XT implantation
The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Sponsors
Northwestern University
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or as a concomitant cardiac operation. 2. Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical pulmonary vein isolation (PVI). 3. Patients 18 years or older. 4. All eligible patients will be considered, regardless of gender or race. 5. Patients able and willing to provide informed consent and willing to comply with the required interval follow-up.
Exclusion criteria
1. Patients with a preoperative permanent pacemaker. 2. Patients with a projected lifespan of less than six months. 3. Patients requiring emergent cardiac surgery. 4. Patients unwilling or unable to give written informed consent. 5. Patients undergoing a right atrial or left atrial lesion set procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals | ILR monitoring obtained at 3, 6 and 12 months |
| Freedom From Atrial Tachyarrhythmias (ATAs) | ILR monitoring at 12 months |
Countries
United States
Participant flow
Recruitment details
A total of 47 consecutive patients who received an implantable loop recorder (ILR) after a surgical ablation procedure were followed between August 2011 and January 2014. Patients with AF who were scheduled to undergo elective surgical ablation procedure that included a CM IV lesion set or pulmonary vein isolation were eligible.
Participants by arm
| Arm | Count |
|---|---|
| Reveal XT Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Reveal XT |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Freedom From Atrial Tachyarrhythmias (ATAs)
Time frame: ILR monitoring at 12 months
Population: Participants with available data at 1 year and who were compliant with use of each device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reveal XT | Freedom From Atrial Tachyarrhythmias (ATAs) | Freedom from ATAs at 1 year, ILR device | 37 Participants |
| Reveal XT | Freedom From Atrial Tachyarrhythmias (ATAs) | Freedom from ATAs at 1 year, Holter monitor | 33 Participants |
| Reveal XT | Freedom From Atrial Tachyarrhythmias (ATAs) | Freedom from ATAs at 1 year, ECG | 37 Participants |
Primary
Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
Time frame: ILR monitoring obtained at 3, 6 and 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Reveal XT | Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals | Count of total ATAs | 20,878 ATA episodes |
| Reveal XT | Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals | Count of reviewed and confirmed ATAs | 1,034 ATA episodes |