Graz Study on the Risk of Atrial Fibrillation

Phase 4

• Conditions: Atrial Fibrillation; Hypertension; Diabetes; Chronic Heart Failure; Vascular Disease
• Interventions: Device: Medtronic Reveal XT implantable loop recorder

• Registration Number: NCT01461434
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-23
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Study Start: 2011-11
• Primary Completion: 2015-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-20
• Last Update Posted: 2015-12-22
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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) ;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
loop recorder	Medtronic Reveal XT implantable loop recorder	patients will be implanted with a subcutaneous loop recorder and have regular follow-ups

Primary Outcome Measures

Name	Time	Method
Time to first diagnosis of atrial fibrillation	12 months

Secondary Outcome Measures

Name	Time	Method
Stroke	12 months
Death	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
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

Trial Locations

Locations (1)

LKH/Uniklinikum - Klinische Abteilung für Kardiologie; 🇦🇹 Graz, Austria