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

NeuroTherapia, Inc.

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: TTM and Holter monitor

Study type: Observational

Funder types: Other

Identifiers

NCT01061125

09-212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

68 participants in 2 patient groups

Unblinded

Description:

Transtelephonic (TTM) monitoring weekly for 5 months Holter monitor recording at 4 months and at 12 months Implantable Loop Recorder (ILR) weekly reports

Treatment:

Other: TTM and Holter monitor

Blinded

Description:

TTM and Holter Monitor conventional follow up Implantable Loop Recorder (ILR) unblinded at 5 months

Treatment:

Other: TTM and Holter monitor