A Comparison of Traditional Arrhythmia Assessment With the Use of Continuous Monitoring to Quantify Postoperative Arrhythmia Burden Following Surgical Treatment of Atrial Fibrillation- Medtronic Reveal XT Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 47
- Locations
- 4
- Primary Endpoint
- Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or as a concomitant cardiac operation.
- •Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical pulmonary vein isolation (PVI).
- •Patients 18 years or older.
- •All eligible patients will be considered, regardless of gender or race.
- •Patients able and willing to provide informed consent and willing to comply with the required interval follow-up.
Exclusion Criteria
- •Patients with a preoperative permanent pacemaker.
- •Patients with a projected lifespan of less than six months.
- •Patients requiring emergent cardiac surgery.
- •Patients unwilling or unable to give written informed consent.
- •Patients undergoing a right atrial or left atrial lesion set procedure.
Outcomes
Primary Outcomes
Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
Time Frame: ILR monitoring obtained at 3, 6 and 12 months
Freedom From Atrial Tachyarrhythmias (ATAs)
Time Frame: ILR monitoring at 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Jennifer Bell
Manager of Research, Cardiothoracic Surgery
Washington University School of Medicine