A Phase 4 interventional study of Solumedrol and Placebo in Atrial Fibrillation, sponsored by Minneapolis Heart Institute Foundation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Minneapolis Heart Institute Foundation · Phase 4, Interventional, and Treatment
Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease inflammation caused by the ablation and thus improve healing and decrease the chance of recurrence of atrial fibrillation.
In this study patients will be randomized to receive intravenous steroids or not immediately following the ablation.
Atrial fibrillation, a common arrhythmia, is the source of considerable morbidity. Prevalence of atrial fibrillation in adults is 0.5%, increasing to 10% in those patients over the age of seventy five. Numbers are expected to increase nearly 2.5 fold over the next 50 years. Radiofrequency (RF) ablation to cure atrial fibrillation has become an established and effective therapy in the many atrial fibrillation patients. However, approximately 20% return with recurrent atrial fibrillation after ablation.
RF ablation directly targets the substrate for atrial fibrillation, cauterizing cardiac tissue through the application of radiofrequency energy , causing a myocardial lesion which effectively blocks the errant pathway. This process of RF ablation induces an inflammatory effect. As the lesion heals it often enlarges. This may contribute to recurrence of atrial fibrillation after ablation, as well as increased pain. There is some early evidence that a single dose of corticosteroids after ablation may improve the healing process, thus decreasing pain and incidence of recurrent atrial fibrillation.
The aim of the study is to determine the usefulness of a one time dose of solumedrol following radiofrequency ablation for atrial fibrillation..
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 119 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Minneapolis Heart Institute Foundation is the lead sponsor of 33 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Solumedrol
Drug: Placebo
100mg, given once within 2 hours of the end of the ablation procedure
Normal saline (1.6 cc)
Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication
Time frame: 6 weeks
Cardiac Pain Assessment
Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
Time frame: one day and one week
Symptoms Post Ablation Requiring Diuretic
Occurrence of shortness of breath or edema requiring administration of a diuretic
Time frame: 6 weeks
Repeat Intervention
Need for repeat ablation
Time frame: 3 months
| Milestone | Steroid | Placebo |
|---|---|---|
| Started | 60 | 59 |
| Completed | 54 | 58 |
| Not completed | 6 | 1 |
Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication
| Participants | Steroid | Placebo |
|---|---|---|
| Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks | 4 | 12 |
Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
| units on a scale | Steroid | Placebo |
|---|---|---|
| Pain Scale Day 1 | 0.9 ± 1.5 | 1.5 ± 2.4 |
| Pain Scale Week 1 | 0.8 ± 1.9 | 0.6 ± 1.2 |
Occurrence of shortness of breath or edema requiring administration of a diuretic
No measurements were reported for this outcome.
Need for repeat ablation
| Participants | Steroid | Placebo |
|---|---|---|
| Repeat Intervention | 2 | 8 |
Collected over there were Adverse Events collected from six weeks to 1 year. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Steroid | — | 0/60 (0%) | 25/60 (41.7%) |
| Placebo | — | 0/59 (0%) | 17/59 (28.8%) |
| Event | Steroid | Placebo |
|---|---|---|
| Shortness of BreathCardiac disorders | 7/60 | 2/59 |
| FatigueCardiac disorders | 6/60 | 1/59 |
| Chest PainCardiac disorders | 1/60 | 5/59 |
| Atrial FlutterCardiac disorders | 5/60 | 3/59 |
| HypotensionCardiac disorders | 0/60 | 3/59 |
| Back PainCardiac disorders | 3/60 | 0/59 |
| Edema/fluid overloadCardiac disorders | 3/60 | 1/59 |
| Abdominal PainCardiac disorders | 0/60 | 2/59 |
| Age, Continuous(years) | Steroid | Placebo | Total |
|---|---|---|---|
| Mean | 60.3 ± 10.2 | 60.0 ± 11.4 | 60.1 ± 11.2 |
| Sex/Gender, Customized(participants) | Steroid | Placebo | Total |
|---|---|---|---|
| Female | 14 | 13 | 27 |
| Male | 46 | 46 | 92 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Minneapolis Heart Institute Foundation