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

Atrial Fibrillation Clinical Trial

— RPAF-A  

Official title:

Implantable Loop Recorders in Post-AF Ablation: RPAF-A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061125
• Other study ID #: 09-212
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: February 9, 2017
• Start date: January 2010
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• TTM and Holter monitor
Standard of care visits recordings reviewed during clinical visits

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF Burden Conventional Follow up	TTM and Holter Monitor Transmissions	Weekly for five months