Medtronic Reveal XT Study

The Washington University

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Device: Reveal XT implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01526343

201105015

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Reveal XT

Experimental group

Treatment:

Device: Reveal XT implantation