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More info
You can access this
clinical trial
if you have
Atrial Fibrillation, Hypertension, Diabetes, Chronic Heart Failure or Vascular Disease
and you are
over 18
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The 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.

Provided treatments

  • Device: Medtronic Reveal XT implantable loop recorder

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01461434. The sponsor of the trial is Medical University of Graz and it is looking for 82 volunteers for the current phase.
Official trial title:
Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients