Graz Study on the Risk of Atrial Fibrillation

Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461434

Acronym

GRAF

Enrollment

Registered

2011-10-28

Start date

2011-11-30

Completion date

2016-01-31

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Chronic Heart Failure, Diabetes, Hypertension, Vascular Disease

Keywords

atrial fibrillation, biomarkers, stroke prevention, implantable loop recorder

Brief 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.

Interventions

DEVICEMedtronic Reveal XT implantable loop recorder

subcutaneous implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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) ;

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026