Medtronic Reveal XT Study
This study is currently recruiting participants.
Verified February 2012 by Washington University School of Medicine
Information provided by (Responsible Party):
Jennifer Bell, Washington University School of Medicine
First received: February 1, 2012
Last updated: February 16, 2012
Last verified: February 2012
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.
Device: Reveal XT implantation
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Number of ATA (atrial tachyarrhythmias) episodes and burden, determined at defined postoperative intervals [ Time Frame: 48 hour Holter monitoring obtained within 90 days of surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Experimental: Reveal XT
Device: 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526343
|Chicago, Illinois, United States, 60611 |
|Contact: Anna Huskin, RN, BSN 312-695-4067 email@example.com |
|Principal Investigator: Richard Lee, MD, MBA |
|Sub-Investigator: Patrick M McCarthy, MD |
|Washington University School of Medicine
|St. Louis, Missouri, United States, 63110 |
|Contact: Donna Marin, RN 314-747-1930 firstname.lastname@example.org |
|Contact: Ralph J Damiano, MD 314-362-7327 |
|Sub-Investigator: Hersh S Maniar, MD |
Washington University School of Medicine
||Ralph J Damiano, MD
||Washington University School of Medicine
No publications provided
||Jennifer Bell, Manager of Research, Cardiothoracic Surgery, Washington University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 1, 2012
||February 16, 2012
||United States: Institutional Review Board
Keywords provided by Washington University School of Medicine:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013