Medtronic Reveal XT Study

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526343
• Other study ID #: 201105015
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2012
• Last updated: August 1, 2017
• Start date: June 2011
• Est. completion date: January 2016

Study information

• Verified date: August 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals		ILR monitoring obtained at 3, 6 and 12 months
Primary	Freedom From Atrial Tachyarrhythmias (ATAs)		ILR monitoring at 12 months