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Medtronic Reveal XT Study

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reveal XT implantation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University
  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reveal XT

Arm Description

Outcomes

Primary Outcome Measures

Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
Freedom From Atrial Tachyarrhythmias (ATAs)

Secondary Outcome Measures

Full Information

First Posted
February 1, 2012
Last Updated
August 1, 2017
Sponsor
Washington University School of Medicine
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01526343
Brief Title
Medtronic Reveal XT Study
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reveal XT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Reveal XT implantation
Intervention Description
The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Primary Outcome Measure Information:
Title
Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals
Time Frame
ILR monitoring obtained at 3, 6 and 12 months
Title
Freedom From Atrial Tachyarrhythmias (ATAs)
Time Frame
ILR monitoring at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph J Damiano, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Medtronic Reveal XT Study

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