Status:
COMPLETED
Medtronic Reveal XT Study
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Northwestern University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 int...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01526343
Start Date
June 1 2011
End Date
January 1 2016
Last Update
August 3 2017
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110