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Corticosteroid Pulse After Ablation (SAAB)

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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
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Solumedrol Drug: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Steroid Drug: Solumedrol
100mg, given once within 2 hours of the end of the ablation procedure

Placebo Comparator: Placebo Drug: Placebo
Normal saline (1.6 cc)




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Perception of cardiac pain assessed by a numerical pain scale [ Time Frame: one day and one week ]
  2. Occurrence of shortness of breath or edema requiring administration of a diuretic [ Time Frame: 6 weeks ]
  3. Need for repeat ablation [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807586


Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
St. Jude Medical
Investigators
Principal Investigator: Daniel P Melby, MD Minneapolis Heart Institute

Publications:
Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00807586     History of Changes
Other Study ID Numbers: ep002
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Minneapolis Heart Institute Foundation:
Atrial Fibrillation
Corticosteroid
Radiofrequency catheter ablation for atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents