Corticosteroid Pulse After Ablation

Atrial Fibrillation Clinical Trial

— SAAB  

Official title:

SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807586
• Other study ID #: ep002
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: July 2019
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Solumedrol
100mg, given once within 2 hours of the end of the ablation procedure
• Placebo
Normal saline (1.6 cc)

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

Grubb NR, Furniss S. Science, medicine, and the future: Radiofrequency ablation for atrial fibrillation. BMJ. 2001 Mar 31;322(7289):777-80. Review. — View Citation

Pappone C, Santinelli V. Atrial fibrillation ablation: state of the art. Am J Cardiol. 2005 Dec 19;96(12A):59L-64L. Epub 2005 Oct 5. Review. — View Citation

Outcome

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