Phase 2
N=47
Medtronic Reveal XT Study
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01526343 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals — 20,878; 1,034 ATA episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Reveal XT implantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals |
20,878; 1,034 | — |
| PRIMARY Freedom From Atrial Tachyarrhythmias (ATAs) |
37; 33; 37 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01526343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.