Graz Study on the Risk of Atrial Fibrillation (GRAF)

December 20, 2015 updated by: Frank R Heinzel, MD, PhD, Medical University of Graz

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH/Uniklinikum - Klinische Abteilung für Kardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: loop recorder
patients will be implanted with a subcutaneous loop recorder and have regular follow-ups
Device: Medtronic Reveal XT implantable loop recorder
subcutaneous implantation
No Intervention: regular follow-up
patients will receive regular follow-ups with standard ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first diagnosis of atrial fibrillation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stroke
Time Frame: 12 months
12 months
Death
Time Frame: 12 months
12 months
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
Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Hospitalizations
Time Frame: 12 months
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
Baseline (0 months), 1,2,3,4,5,6,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

October 23, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAF-01-SCCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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