Corticosteroid Pulse After Ablation (SAAB)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00807586
First received: December 10, 2008
Last updated: April 23, 2013
Last verified: April 2013

December 10, 2008
April 23, 2013
December 2008
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00807586 on ClinicalTrials.gov Archive Site
  • Perception of cardiac pain assessed by a numerical pain scale [ Time Frame: one day and one week ] [ Designated as safety issue: No ]
  • Occurrence of shortness of breath or edema requiring administration of a diuretic [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Need for repeat ablation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Corticosteroid Pulse After Ablation
SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation

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.

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..

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: Solumedrol
    100mg, given once within 2 hours of the end of the ablation procedure
  • Drug: Placebo
    Normal saline (1.6 cc)
  • Experimental: Steroid
    Intervention: Drug: Solumedrol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2013
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00807586
ep002
No
Minneapolis Heart Institute Foundation
Minneapolis Heart Institute Foundation
St. Jude Medical
Principal Investigator: Daniel P Melby, MD Minneapolis Heart Institute
Minneapolis Heart Institute Foundation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP