Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, implantable loop recorder, TTM
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.
Interventions
Standard of care visits recordings reviewed during clinical visits
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AF Burden Conventional Follow up | Weekly for five months | TTM and Holter Monitor Transmissions |
Countries
United States