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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: January 29, 2016
Last verified: January 2016
  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
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Enrollment: 68
Study Start Date: January 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
TTM/ Holter
ILR

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

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: RPAF-A 
Study First Received: February 1, 2010
Last Updated: January 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: PHI will be protected.

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

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

ClinicalTrials.gov processed this record on September 23, 2016