Medtronic Reveal XT Study

Washington University School of Medicine47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Reveal XT implantationDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Northwestern University

Chicago, Illinois, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: ILR monitoring obtained at 3, 6 and 12 months

Freedom From Atrial Tachyarrhythmias (ATAs)

Time frame: ILR monitoring at 12 months

Data from ClinicalTrials.gov

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