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Medtronic Reveal XT Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01526343
Recruitment Status : Completed
First Posted : February 3, 2012
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Jennifer Bell, Washington University School of Medicine

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Reveal XT implantation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals [ Time Frame: ILR monitoring obtained at 3, 6 and 12 months ]
  2. Freedom From Atrial Tachyarrhythmias (ATAs) [ Time Frame: ILR monitoring at 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526343


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Northwestern University
Investigators
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Principal Investigator: Ralph J Damiano, MD Washington University School of Medicine
More Information
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Responsible Party: Jennifer Bell, Manager of Research, Cardiothoracic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01526343    
Other Study ID Numbers: 201105015
First Posted: February 3, 2012    Key Record Dates
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: August 2017
Keywords provided by Jennifer Bell, Washington University School of Medicine:
Patients
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes