Medtronic Reveal XT Study

NCT01526343 | Completed Phase 2 Results DMC

• 1 other identifier: 201105015
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Keywords

Patients

Outcome Measures

Primary Outcomes (2)

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

  ILR monitoring obtained at 3, 6 and 12 months

• Freedom From Atrial Tachyarrhythmias (ATAs)

  ILR monitoring at 12 months

Study Arms (1)

Reveal XT

EXPERIMENTAL

Device: Reveal XT implantation

Interventions

Reveal XT implantation DEVICE

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

Reveal XT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Northwestern University: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jennifer Bell, Manager of Clinical Trials
• Organization: Washington University School of Medicine

jennifer.bell@wustl.edu

314-747-6969

Study Officials

• Ralph J Damiano, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of Research, Cardiothoracic Surgery

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: June 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 3, 2017
• Results First Posted: August 3, 2017

Record last verified: 2017-08

Locations

US (2)