Corticosteroid Pulse After Ablation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Solumedrol; Drug: Placebo

• Registration Number: NCT00807586
• Lead Sponsor: Minneapolis Heart Institute Foundation

Brief 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.

Detailed Description

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..

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Primary Completion: 2009-12
• Study Completion: 2013-12
• Results First Submitted: 2013-12-03
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-29
• Last Update Submitted: 2019-07-29
• Results First Posted: 2019-08-20
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid	Solumedrol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks	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

Secondary Outcome Measures

Name	Time	Method
Cardiac Pain Assessment	one day and one week	Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
Symptoms Post Ablation Requiring Diuretic	6 weeks	Occurrence of shortness of breath or edema requiring administration of a diuretic
Repeat Intervention	3 months	Need for repeat ablation

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States