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
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: Solumedrol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation

Resource links provided by NLM:


Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00807586     History of Changes
Other Study ID Numbers: ep002
Study First Received: December 10, 2008
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

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 acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014