Clinical trial NCT00807586: Corticosteroid Pulse After Ablation
Official title: SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Corticosteroid
Radiofrequency catheter ablation for atrial fibrillation
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2008-12-12
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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..

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

Primary outcomes:
measure: Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Cardiac Pain Assessment
timeFrame: one day and one week
measure: Symptoms Post Ablation Requiring Diuretic
timeFrame: 6 weeks
measure: Repeat Intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute
name: Daniel P Melby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grubb NR, Furniss S. Science, medicine, and the future: Radiofrequency ablation for atrial fibrillation. BMJ. 2001 Mar 31;322(7289):777-80. doi: 10.1136/bmj.322.7289.777. No abstract available.
citation: Pappone C, Santinelli V. Atrial fibrillation ablation: state of the art. Am J Cardiol. 2005 Dec 19;96(12A):59L-64L. doi: 10.1016/j.amjcard.2005.09.063. Epub 2005 Oct 5.
citation: Fenelon G, Franco M, Mora O, Katchburian E, de Paola AA. Combined therapy with steroids and antioxidants prevents ultrastructural damage surrounding chronic radiofrequency lesions. Pacing Clin Electrophysiol. 2004 Jan;27(1):65-72. doi: 10.1111/j.1540-8159.2004.00387.x.
citation: Fenelon G, Fernandes R, Franco M, de Paola AA. Steroids prevent late extension of radiofrequency lesions in the thigh muscle of infant rats: implications for pediatric ablation. J Interv Card Electrophysiol. 2003 Aug;9(1):7-13. doi: 10.1023/a:1025308218103.