Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation

Stopped early · Phase 4

Conditions studied: Atrial Fibrillation

In brief

This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an anti-coagulant for a period of one year to see if there are any significant changes in the degree of left atrial structural remodeling in these patients. The investigators hypothesize that there will be a significant decrease in the degree of left atrial structural remodeling (fibrosis) in AF patients treated with dabigatran.

Key facts

Study ID

NCT01546883

Run by

University of Utah

People needed

14

Starts

2012-02-01

Expected to finish

2013-12-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with all types of non-valvular AF (includes paroxysmal, persistent and permanent AF)
• Candidate for anticoagulation therapy
• No contra-indication for LGE-MRI
• Patients age 18 and older
• Patients who are able to provide informed consent to participate in the study

You may not qualify if…

• Patients who have already undergone an atrial fibrillation ablation procedure.
• Patients with active contra-indications to any anticoagulant agent.
• Other major bleeding disorders or risk factors that would place the patient at risk of bleeding.
• Recent surgery (within 30 days).
• Renal insufficiency, severe kidney disorders/diseases, GFR < 30mg/dL (Gadolinium contraindication).
• Advanced liver disease.
• Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.
• Pregnant, planning to be become pregnant or nursing women
• Individuals who are unable to provide informed consent
• Contraindicated for Pradaxa® .
• Patients the Investigators feel are inappropriate for the study
• Patients who cannot give informed consent

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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