Phase 3
Completed N=33
SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI
Source: ClinicalTrials.gov NCT01182376 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: LA Fibrosis — 24.6; 16.8 percentage of fibrosis
Summary
The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LA Fibrosis |
24.6; 16.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients age 18 and older
- Must carry a diagnosis of Paroxysmal Atrial Fibrillation for 1 months or longer prior to being enrolled.
- AAD: Multaq® (dronedarone) candidate
- Patients have given informed consent
Exclusion Criteria
- Patients who are unavailable to continue follow-up at the University of Utah outpatient clinic.
- Patients weighing >200 lbs (MR image efficacy decreases due to density)
- Prior RF Ablation treatment for atrial fibrillation
- Severe renal failure manifested by a chronic GFR of 280 ms
- Severe hepatic impairment
- Pregnant women
- Nursing mothers
Data sourced from ClinicalTrials.gov (NCT01182376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.