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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061125
First Posted: February 2, 2010
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Walid Saliba, The Cleveland Clinic
  Purpose
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.

Condition Intervention
Atrial Fibrillation Other: TTM and Holter monitor

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Implantable Loop Recorders in Post-AF Ablation: RPAF-A

Resource links provided by NLM:


Further study details as provided by Walid Saliba, The Cleveland Clinic:

Primary Outcome Measures:
  • AF Burden Conventional Follow up [ Time Frame: Weekly for five months ]
    TTM and Holter Monitor Transmissions


Enrollment: 68
Actual Study Start Date: January 2010
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Unblinded
Transtelephonic (TTM) monitoring weekly for 5 months Holter monitor recording at 4 months and at 12 months Implantable Loop Recorder (ILR) weekly reports
Other: TTM and Holter monitor
Standard of care visits recordings reviewed during clinical visits
Other Name: Transtelephonic monitoring
Blinded
TTM and Holter Monitor conventional follow up Implantable Loop Recorder (ILR) unblinded at 5 months
Other: TTM and Holter monitor
Standard of care visits recordings reviewed during clinical visits
Other Name: Transtelephonic monitoring

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting for atrial fibrillation ablation
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061125


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44193
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Walid Saliba, MD The Cleveland Clinic
Study Director: Oussama Wazni, MD The Cleveland Clinic
  More Information

Responsible Party: Walid Saliba, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01061125     History of Changes
Other Study ID Numbers: 09-212
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Walid Saliba, The Cleveland Clinic:
atrial fibrillation
implantable loop recorder
TTM

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes