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| Sponsor: | The Cleveland Clinic |
|---|---|
| Information provided by: | The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01061125 |
Purpose
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 determine the detection of symptomatic and asymptomatic post ablation AF and aid in decision making regarding anticoagulation and overall post ablation clinical management.
| Condition |
|---|
|
Atrial Fibrillation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Implantable Loop Recorders in Post-AF Ablation: RPAF-A |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| TTM/ Holter |
| ILR |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients presenting for atrial fibrillation ablation
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tina Sewell, RN, BSN | 216-444-3270 | sewellc@ccf.org |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44193 | |
| Contact: Tina Sewell, RN, BSN 216-444-3270 sewellc@ccf.org | |
| Principal Investigator: Walid Saliba, MD | |
| Sub-Investigator: Oussama Wazni, MD | |
| Principal Investigator: | Walid Saliba, MD | The Cleveland Clinic |
| Study Director: | Oussama Wazni, MD | The Cleveland Clinic |
More Information
| Responsible Party: | Walid Saliba, MD, Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01061125 History of Changes |
| Other Study ID Numbers: | RPAF-A |
| Study First Received: | February 1, 2010 |
| Last Updated: | February 10, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
atrial fibrillation implantable loop recorder TTM |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |