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Graz Study on the Risk of Atrial Fibrillation

NCT ID: NCT01461434

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Hypertension Diabetes Chronic Heart Failure Vascular Disease

Keywords

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atrial fibrillation biomarkers stroke prevention implantable loop recorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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loop recorder

patients will be implanted with a subcutaneous loop recorder and have regular follow-ups

Group Type EXPERIMENTAL

Medtronic Reveal XT implantable loop recorder

Intervention Type DEVICE

subcutaneous implantation

regular follow-up

patients will receive regular follow-ups with standard ECG

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medtronic Reveal XT implantable loop recorder

subcutaneous implantation

Intervention Type DEVICE

Eligibility Criteria

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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) ;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Frank R Heinzel, MD, PhD

Associate Professor Frank R. Heinzel, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LKH/Uniklinikum - Klinische Abteilung für Kardiologie

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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GRAF-01-SCCT

Identifier Type: -

Identifier Source: org_study_id