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



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:2/11/2017
Start Date:January 2010
End Date:October 2016

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

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.

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.

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
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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