Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, hypertension, diabetes, chronic heart failure, vascular disease
Treatment medtronic reveal xt implantable loop recorder
Phase phase 4
Sponsor Medical University of Graz
Collaborator Medtronic
Start date November 2011
End date May 2015
Trial size 82 participants
Trial identifier NCT01461434, GRAF-01-SCCT

Summary

Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.

Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
patients will be implanted with a subcutaneous loop recorder and have regular follow-ups
medtronic reveal xt implantable loop recorder
subcutaneous implantation
(No Intervention)
patients will receive regular follow-ups with standard ECG

Primary Outcomes

Measure
Time to first diagnosis of atrial fibrillation
time frame: 12 months

Secondary Outcomes

Measure
Time to change in therapy based on the diagnosis of atrial fibrillation
time frame: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Hospitalizations
time frame: 12 months
Change in NTproBNP serum level associated with occurrence of atrial fibrillation
time frame: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Death
time frame: 12 months
Stroke
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - CHA2DS2-VASc risk score >= 4* - 18 years or older Exclusion Criteria: - known history of atrial fibrillation - implanted rhythm device - pre-existing indication for oral anticoagulation (*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age >= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age >=65 and < 75 years (1 point); Sc - sex category (female) (1 point) ;

Additional Information

Official title Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Medical University of Graz.