Medtronic Reveal XT Study
Completed · Phase 2
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT01526343
- Run by
- Washington University School of Medicine
- People needed
- 47
- Starts
- 2011-06-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Northwestern University — Chicago, Illinois, United States
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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