Graz Study on the Risk of Atrial Fibrillation (GRAF)

This study is currently recruiting participants.
Verified February 2014 by Medical University of Graz
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Heinzel Frank, MD PhD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01461434
First received: October 23, 2011
Last updated: February 9, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Hypertension
Diabetes
Chronic Heart Failure
Vascular Disease
Device: Medtronic Reveal XT implantable loop recorder
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Time to first diagnosis of atrial fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: November 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) ;

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461434

Contacts
Contact: Frank R Heinzel, MD,PhD +43316385 ext 80772 graf@studienambulanz.at

Locations
Austria
LKH/Uniklinikum - Klinische Abteilung für Kardiologie Recruiting
Graz, Austria, 8036
Contact: Frank R Heinzel, MD,PhD    +43316385 ext 80772    frank.heinzel@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Medtronic
  More Information

No publications provided

Responsible Party: Heinzel Frank, MD PhD, Associate Professor Frank R. Heinzel, MD, PhD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01461434     History of Changes
Other Study ID Numbers: GRAF-01-SCCT
Study First Received: October 23, 2011
Last Updated: February 9, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
atrial fibrillation
biomarkers
stroke prevention
implantable loop recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Hypertension
Vascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014