Medtronic Reveal XT Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Washington University School of Medicine
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Jennifer Bell, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01526343
First received: February 1, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Atrial Fibrillation
Device: Reveal XT implantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

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: 100
Study Start Date: June 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526343

Contacts
Contact: Donna Marin, RN 314-747-1930 marind@wudosis.wustl.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin, RN, BSN    312-695-4067    ahuskin@nmh.org   
Principal Investigator: Richard Lee, MD, MBA         
Sub-Investigator: Patrick M McCarthy, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Donna Marin, RN    314-747-1930    marind@wudosis.wust.edu   
Contact: Ralph J Damiano, MD    314-362-7327      
Sub-Investigator: Hersh S Maniar, MD         
Sponsors and Collaborators
Washington University School of Medicine
Northwestern University
Investigators
Principal Investigator: Ralph J Damiano, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jennifer Bell, Manager of Research, Cardiothoracic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01526343     History of Changes
Other Study ID Numbers: 201105015
Study First Received: February 1, 2012
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Patients

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014