Phase 4
N=119
Corticosteroid Pulse After Ablation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00807586 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks — 4; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Solumedrol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Minneapolis Heart Institute Foundation
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks |
4; 12 | — |
| SECONDARY Cardiac Pain Assessment |
0.9; 1.5; 0.8; 0.6 | — |
| SECONDARY Symptoms Post Ablation Requiring Diuretic |
— | — |
| SECONDARY Repeat Intervention |
2; 8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18
- Drug refractory, symptomatic paroxysmal atrial fibrillation
Exclusion Criteria
- Contraindication to solumedrol
- Persistent or permanent Atrial Fibrillation
- Previous history of radiofrequency ablation for atrial fibrillation
Data sourced from ClinicalTrials.gov (NCT00807586). 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.