Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01061125
First received: February 1, 2010
Last updated: February 10, 2010
Last verified: February 2010
  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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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
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

Contacts
Contact: Tina Sewell, RN, BSN 216-444-3270 sewellc@ccf.org

Locations
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         
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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on November 27, 2014