Medtronic Reveal XT Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
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
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.
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.
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.
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