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Completed

NCT Number: NCT01206452

Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

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.

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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

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

The purpose of this study is:

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Prednisone

Drug

60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure

Placebo

Other

60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure

Ablation procedure

Procedure

Atrial Fibrillation (AF) ablation

Primary outcomes

  1. Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months

    Time frame: 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 outcomes

  1. Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months

    Time frame: 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.

  2. Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months

    Time frame: 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.

  3. Inflammatory Cytokine Response to Ablation Procedure

    Time frame: Immediately Post-Ablation Procedure

    Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.

  4. Inflammatory Cytokine Response to Ablation Procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dhanunjaya Lakkireddy, MD, FACC

Other

Registry information

Official study title

Use of Oral Steroids Before Circumferential Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation to Improve Outcomes

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2010
Registry last updated
May 17, 2017

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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