Medtronic Reveal XT Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reveal XT

Group Type EXPERIMENTAL

Reveal XT implantation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No