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Corticosteroid Pulse After Ablation (SAAB)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solumedrol
Placebo
Sponsored by
Minneapolis Heart Institute Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Corticosteroid, Radiofrequency catheter ablation for atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abbott Northwestern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Steroid

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Clinically Significant Atrial Arrhythmias at 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 Outcome Measures

Cardiac Pain Assessment
Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
Symptoms Post Ablation Requiring Diuretic
Occurrence of shortness of breath or edema requiring administration of a diuretic
Repeat Intervention
Need for repeat ablation

Full Information

First Posted
December 10, 2008
Last Updated
July 29, 2019
Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00807586
Brief Title
Corticosteroid Pulse After Ablation
Acronym
SAAB
Official Title
SAAB: Randomized, Double Blind STudy of Corticosteroid Pulse After Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Corticosteroid, Radiofrequency catheter ablation for atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steroid
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Solumedrol
Intervention Description
100mg, given once within 2 hours of the end of the ablation procedure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline (1.6 cc)
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Cardiac Pain Assessment
Description
Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
Time Frame
one day and one week
Title
Symptoms Post Ablation Requiring Diuretic
Description
Occurrence of shortness of breath or edema requiring administration of a diuretic
Time Frame
6 weeks
Title
Repeat Intervention
Description
Need for repeat ablation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Melby, MD
Organizational Affiliation
Minneapolis Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11282867
Citation
Grubb NR, Furniss S. Science, medicine, and the future: Radiofrequency ablation for atrial fibrillation. BMJ. 2001 Mar 31;322(7289):777-80. doi: 10.1136/bmj.322.7289.777. No abstract available.
Results Reference
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PubMed Identifier
16399094
Citation
Pappone C, Santinelli V. Atrial fibrillation ablation: state of the art. Am J Cardiol. 2005 Dec 19;96(12A):59L-64L. doi: 10.1016/j.amjcard.2005.09.063. Epub 2005 Oct 5.
Results Reference
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PubMed Identifier
14720157
Citation
Fenelon G, Franco M, Mora O, Katchburian E, de Paola AA. Combined therapy with steroids and antioxidants prevents ultrastructural damage surrounding chronic radiofrequency lesions. Pacing Clin Electrophysiol. 2004 Jan;27(1):65-72. doi: 10.1111/j.1540-8159.2004.00387.x.
Results Reference
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PubMed Identifier
12975564
Citation
Fenelon G, Fernandes R, Franco M, de Paola AA. Steroids prevent late extension of radiofrequency lesions in the thigh muscle of infant rats: implications for pediatric ablation. J Interv Card Electrophysiol. 2003 Aug;9(1):7-13. doi: 10.1023/a:1025308218103.
Results Reference
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Corticosteroid Pulse After Ablation

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