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

Study Overview
=================
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.

Official Title
-----------------
Implantable Loop Recorders in Post-AF Ablation: RPAF-A

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: TTM and Holter monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unblinded<br>Transtelephonic (TTM) monitoring weekly for 5 months Holter monitor recording at 4 months and at 12 months Implantable Loop Recorder (ILR) weekly reports | Other: TTM and Holter monitor<br>* Standard of care visits recordings reviewed during clinical visits<br>* Other names: Transtelephonic monitoring;|
| Blinded<br>TTM and Holter Monitor conventional follow up Implantable Loop Recorder (ILR) unblinded at 5 months | Other: TTM and Holter monitor<br>* Standard of care visits recordings reviewed during clinical visits<br>* Other names: Transtelephonic monitoring;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF Burden Conventional Follow up | TTM and Holter Monitor Transmissions | Weekly for five months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, implantable loop recorder, TTM