Overview
Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation
Status:
Terminated
Terminated
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of UtahTreatments:
Dabigatran
Criteria
Inclusion Criteria:1. Patients with all types of non-valvular AF (includes paroxysmal, persistent and
permanent AF)
2. Candidate for anticoagulation therapy
3. No contra-indication for LGE-MRI
4. Patients age 18 and older
5. Patients who are able to provide informed consent to participate in the study
Exclusion Criteria:
1. Patients who have already undergone an atrial fibrillation ablation procedure.
2. Patients with active contra-indications to any anticoagulant agent.
3. Other major bleeding disorders or risk factors that would place the patient at risk of
bleeding.
4. Recent surgery (within 30 days).
5. Renal insufficiency, severe kidney disorders/diseases, GFR < 30mg/dL (Gadolinium
contraindication).
6. Advanced liver disease.
7. Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.
8. Pregnant, planning to be become pregnant or nursing women
9. Individuals who are unable to provide informed consent
10. Contraindicated for Pradaxa® .
11. Patients the Investigators feel are inappropriate for the study
12. Patients who cannot give informed consent