Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment reveal implantable cardiac monitor
Sponsor Medtronic Cardiac Rhythm and Heart Failure
Start date October 2012
End date January 2017
Trial size 450 participants
Trial identifier NCT01727297, REVEAL AF

Summary

This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients after AF has been detected. This study will also seek to identify what patient characteristics are most predictive of developing AF.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Other)
reveal implantable cardiac monitor

Primary Outcomes

Measure
Time to first Atrial Fibrillation lasting six or more minutes.
time frame: Implant to 18 month follow-up visit

Secondary Outcomes

Measure
Predictors of Atrial Fibrillation
time frame: Time from implant to date of last stored available implanted device data (maximum of 30 months)
Actions taken in response to awareness of atrial fibrillation
time frame: Time from first identified episode of atrial fibrillation to study exit (maximum of 30 months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient meets the approved indications to receive the Reveal ICM - Patient is suspected, based on symptomatology and/or demographics, of having atrial fibrillation or at high risk of having AF, as determined by the clinical investigator - Patient has a CHADS2 score ≥ 3 OR has a CHADS2 score = 2 WITH at least one of the following documented: Renal impairment (GFR 30-60 ml/min, sleep apnea, coronary artery disease, or chronic obstructive pulmonary disease. Note: stroke/TIA criterion as part of the CHADS2 score for this trial is limited to either an ischemic stroke or TIA, which occurred MORE THAN one year prior to enrollment. - Patient is 18 years of age or older - Patient has a life expectancy of 18 months or more - Patient, or legally authorized representative, is willing to sign and date the consent form - Patient is willing and able to be remotely monitored (i.e., eligible for enrollment into the Medtronic CareLink Network) Exclusion Criteria: - Patient has a documented history of AF or atrial flutter - Patient had an ischemic stroke or TIA within past year prior to enrollment - Patient has a history of a hemorrhagic stroke - Patient is currently implanted with an IPG, ICD, CRT-P, or CRT-D device - NYHA Class IV Heart Failure patient - Patient had heart surgery within previous 90 days prior to enrollment - Patient had an MI within the previous 90 days prior to enrollment - Patient is taking chronic immuno-suppressant therapy - Patient is taking an anti-arrhythmic drug - Patient is contraindicated for long term anticoagulation medication - Patient is taking a long-term anticoagulation medication - Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis) - Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager - Patient has a creatinine clearance <30 ml/min or is on dialysis

Additional Information

Official title Reveal XT Implantable Cardiac Monitor
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm and Heart Failure.