SAAB: Corticosteroid Pulse After Ablation

• Sponsor: Minneapolis Heart Institute Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00807586
• Collaborator: Abbott Medical Devices (Industry)
• Enrollment: 119
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 2

Study Details

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.

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 Design

• Study Type: Interventional
• Actual Enrollment: 119 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: Dec 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

1. Cardiac Pain Assessment [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 [6 weeks]

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

3. Repeat Intervention [3 months]

   Need for repeat ablation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407

Sponsors and Collaborators

• Minneapolis Heart Institute Foundation
• Abbott Medical Devices

Investigators

• Principal Investigator: Daniel P Melby, MD, Minneapolis Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Grubb NR, Furniss S. Science, medicine, and the future: Radiofrequency ablation for atrial fibrillation. BMJ. 2001 Mar 31;322(7289):777-80. Review.
• Pappone C, Santinelli V. Atrial fibrillation ablation: state of the art. Am J Cardiol. 2005 Dec 19;96(12A):59L-64L. Epub 2005 Oct 5. Review.

• Responsible Party: Minneapolis Heart Institute Foundation
• ClinicalTrials.gov Identifier: NCT00807586
• Other Study ID Numbers: ep002
• First Posted: Dec 12, 2008
• Last Update Posted: Aug 20, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Minneapolis Heart Institute Foundation: Atrial Fibrillation; Corticosteroid; Radiofrequency catheter ablation for atrial fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation; Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Methylprednisolone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure	Placebo: Normal saline (1.6 cc)
Period Title: Overall Study
STARTED	60	59
COMPLETED	54	58
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	Steroid	Placebo	Total
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure	Placebo: Normal saline (1.6 cc)	Total of all reporting groups
Overall Participants	60	59	119
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.3 (10.2)	60.0 (11.4)	60.1 (11.2)
Sex/Gender, Customized (participants) [Number]
Female	14 23.3%	13 22%	27 22.7%
Male	46 76.7%	46 78%	92 77.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

3 patients lost to follow-up

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure	Placebo: Normal saline (1.6 cc)
Measure Participants	58	58
Count of Participants [Participants]	4 6.7%	12 20.3%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

4 patients lost to follow up

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure	Placebo: Normal saline (1.6 cc)
Measure Participants	58	57
Pain Scale Day 1	0.9 (1.5)	1.5 (2.4)
Pain Scale Week 1	0.8 (1.9)	0.6 (1.2)

3. Secondary Outcome

Title	Symptoms Post Ablation Requiring Diuretic
Description	Occurrence of shortness of breath or edema requiring administration of a diuretic
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected on this outcome

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure	Placebo: Normal saline (1.6 cc)
Measure Participants	0	0

4. Secondary Outcome

Title	Repeat Intervention
Description	Need for repeat ablation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

14 patients lost to follow up

Arm/Group Title	Steroid	Placebo
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure	Placebo: Normal saline (1.6 cc)
Measure Participants	50	55
Count of Participants [Participants]	2 3.3%	8 13.6%

Adverse Events

Time Frame	there were Adverse Events collected from six weeks to 1 year
Arm/Group Title	Steroid		Placebo
Arm/Group Description	Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure		Placebo: Normal saline (1.6 cc)
All Cause Mortality
	Steroid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Steroid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Steroid		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/60 (41.7%)		17/59 (28.8%)
Cardiac disorders
Atrial Flutter	5/60 (8.3%)	5	3/59 (5.1%)	3
Chest Pain	1/60 (1.7%)	1	5/59 (8.5%)	5
Shortness of Breath	7/60 (11.7%)	7	2/59 (3.4%)	2
Fatigue	6/60 (10%)	6	1/59 (1.7%)	1
Back Pain	3/60 (5%)	3	0/59 (0%)	0
Edema/fluid overload	3/60 (5%)	3	1/59 (1.7%)	1
Hypotension	0/60 (0%)	0	3/59 (5.1%)	3
Abdominal Pain	0/60 (0%)	0	2/59 (3.4%)	2

Limitations/Caveats

This was a single center study trial

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.