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Completed

NCT Number: NCT01526343

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Reveal XT implantation

Device

The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Northwestern University

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2012
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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