Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Placebo; Drug: Prednisone; Procedure: Ablation Procedure

• Registration Number: NCT01206452
• Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC

Brief Summary

The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.

Detailed Description

The purpose of this study is:

1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.

2. To measure the inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2016-01-25
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-11
• Last Update Submitted: 2017-04-11
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Able to provide written informed consent;
2. Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation

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Exclusion Criteria

1. History of heart failure (right or left or biventricular) or cardiomyopathy.
2. Immunosuppressive disorders and systemic fungal infection
3. Concurrent use of corticosteroids in one week prior recruitment.
4. Allergy or prednisone or its components.
5. Other medical conditions were use of corticosteroids is not recommended or contraindicated.
6. Patients with chronic and permanent atrial fibrillation.
7. Patients with established diagnosis of rheumatological and immunological disorders.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation plus prednisone	Ablation Procedure	Participants undergo ablation procedure and receive predinisone at protocol determined times.
Ablation plus placebo	Placebo	Participants undergo ablation procedure and receive placebo at protocol determined times.
Ablation plus placebo	Ablation Procedure	Participants undergo ablation procedure and receive placebo at protocol determined times.
Ablation plus prednisone	Prednisone	Participants undergo ablation procedure and receive predinisone at protocol determined times.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months	From 6 months up to 12 months post-procedure	Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.

Secondary Outcome Measures

Name	Time	Method
Inflammatory Cytokine Response to Ablation Procedure	24 Hours after Ablation Procedure	Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.
Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months	From 0 months up to 3 months post procedure	Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months	From 3 months up to 6 months post-procedure	Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.

Trial Locations

Locations (1)

University Of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States