Implantable Loop Recorders in Post-atrial Fibrillation (AF) Ablation: RPAF-A

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: TTM and Holter monitor

• Registration Number: NCT01061125
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to determine the clinical utility of the Implantable Loop Recorder. These type of patients either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR). The Medtronic Reveal XT loop recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on randomization to a blinded or unblinded group. Outcome measures will be compared to aid in decision making regarding anticoagulation and overall post ablation clinical management.

Detailed Description

This is a randomized pilot study, of post pulmonary vein isolation (PVI) patients to determine the clinical utility of the Implantable Loop Recorder. The Medtronic Reveal XT implantable Loop Recorder is a market released device indicated for patients with clinical syndromes or situations at increased risk of cardiac arrhythmias, and patients who experience transient symptoms that may suggest a cardiac arrhythmia. These type of patients either are monitored with weekly transtelephonic monitoring (TTM) or implantable loop recorder (ILR). Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice. The Medtronic Reveal XT loop recorder will be implanted at the time of the PVI or at the 3-4 month PVI follow-up visit and patient care will be managed based on randomization to a blinded or unblinded group. Outcome measures will be compared to aid in decision making regarding anticoagulation and overall post ablation clinical management.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• atrial fibrillation
• Chads score > or equal to 1

Exclusion Criteria

• contraindication for ILR
• life expectancy less an 12 months
• pregnant women
• existing cardiac rhythm management (CRM) device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blinded	TTM and Holter monitor	TTM and Holter Monitor conventional follow up Implantable Loop Recorder (ILR) unblinded at 5 months
Unblinded	TTM and Holter monitor	Transtelephonic (TTM) monitoring weekly for 5 months Holter monitor recording at 4 months and at 12 months Implantable Loop Recorder (ILR) weekly reports

Primary Outcome Measures

Name	Time	Method
AF Burden Conventional Follow up	Weekly for five months	TTM and Holter Monitor Transmissions

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States