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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walid Saliba, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01061125
First received: February 1, 2010
Last updated: February 9, 2017
Last verified: February 2017
February 1, 2010
February 9, 2017
January 2010
October 2016   (Final data collection date for primary outcome measure)
AF Burden Conventional Follow up [ Time Frame: Weekly for five months ]
TTM and Holter Monitor Transmissions
Not Provided
Complete list of historical versions of study NCT01061125 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Implantable Loop Recorders in Post-atrial Fibrillation (AF) Ablation: RPAF-A
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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients presenting for atrial fibrillation ablation
Atrial Fibrillation
Other: TTM and Holter monitor
Standard of care visits recordings reviewed during clinical visits
Other Name: Transtelephonic monitoring
  • Unblinded
    Transtelephonic (TTM) monitoring weekly for 5 months Holter monitor recording at 4 months and at 12 months Implantable Loop Recorder (ILR) weekly reports
    Intervention: Other: TTM and Holter monitor
  • Blinded
    TTM and Holter Monitor conventional follow up Implantable Loop Recorder (ILR) unblinded at 5 months
    Intervention: Other: TTM and Holter monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
October 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01061125
09-212
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Walid Saliba, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Walid Saliba, MD The Cleveland Clinic
Study Director: Oussama Wazni, MD The Cleveland Clinic
The Cleveland Clinic
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP