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

NCT01061125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2017-02-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

TTM and Holter monitor

Standard of care visits recordings reviewed during clinical visits

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Walid Saliba, MD · The Cleveland Clinic

  • Oussama Wazni, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061125 on ClinicalTrials.gov