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OpenTrials
Completed

NCT Number: NCT00807586

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solumedrol

Drug

100mg, given once within 2 hours of the end of the ablation procedure

Placebo

Drug

Normal saline (1.6 cc)

Primary outcomes

  1. Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks

    Time frame: 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

Secondary outcomes

  1. Cardiac Pain Assessment

    Time frame: one day and one week

    Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)

  2. Symptoms Post Ablation Requiring Diuretic

    Time frame: 6 weeks

    Occurrence of shortness of breath or edema requiring administration of a diuretic

  3. Repeat Intervention

    Time frame: 3 months

    Need for repeat ablation

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Acronym: SAAB

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Dec 12, 2008
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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