Skip to main content
OpenTrials
Completed

NCT Number: NCT01061125

Implantable Loop Recorders in Post-atrial Fibrillation (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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44193, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTM and Holter monitor

Other

Standard of care visits recordings reviewed during clinical visits

Other names: Transtelephonic monitoring

Primary outcomes

  1. AF Burden Conventional Follow up

    Time frame: Weekly for five months

    TTM and Holter Monitor Transmissions

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: RPAF-A

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2010
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.