Corticosteroid Pulse After Ablation (SAAB)
|ClinicalTrials.gov Identifier: NCT00807586|
Recruitment Status : Unknown
Verified April 2013 by Minneapolis Heart Institute Foundation.
Recruitment status was: Active, not recruiting
First Posted : December 12, 2008
Last Update Posted : April 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Solumedrol Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2013|
100mg, given once within 2 hours of the end of the ablation procedure
|Placebo Comparator: Placebo||
Normal saline (1.6 cc)
- Composite of severe symptomatic atrial arrythmias, clinically significant atrial arrhythmias lasting >24 hours requiring initiation or change in drug therapy, hospitalization for arrythmias or cardioversion during the initial 6 weeks post ablation [ Time Frame: 6 weeks ]
- Perception of cardiac pain assessed by a numerical pain scale [ Time Frame: one day and one week ]
- Occurrence of shortness of breath or edema requiring administration of a diuretic [ Time Frame: 6 weeks ]
- Need for repeat ablation [ Time Frame: 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807586
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Daniel P Melby, MD||Minneapolis Heart Institute|