NCT00807586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

December 10, 2008

Results QC Date

December 3, 2013

Last Update Submit

July 29, 2019

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCorticosteroidRadiofrequency catheter ablation for atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks

Secondary Outcomes (3)

  • Cardiac Pain Assessment

    one day and one week

  • Symptoms Post Ablation Requiring Diuretic

    6 weeks

  • Repeat Intervention

    3 months

Study Arms (2)

Steroid

EXPERIMENTAL
Drug: Solumedrol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SolumedrolDRUG

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

Steroid
PlaceboDRUG

Normal saline (1.6 cc)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Drug refractory, symptomatic paroxysmal atrial fibrillation

You may not qualify if:

  • Contraindication to solumedrol
  • Persistent or permanent Atrial Fibrillation
  • Previous history of radiofrequency ablation for atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (4)

  • 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.

    PMID: 11282867BACKGROUND

  • 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.

    PMID: 16399094BACKGROUND

  • 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.

    PMID: 14720157BACKGROUND

  • 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.

    PMID: 12975564BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

This was a single center study trial

Results Point of Contact

Title
Dr. Daniel Melby
Organization
Minneapolis Heart Institute Foundation
daniel.melby@allina.com
612-863-3900

Study Officials

  • Daniel P Melby, MD

    Minneapolis Heart Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 12, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2013

Last Updated

August 20, 2019

Results First Posted

August 20, 2019

Record last verified: 2019-07

Locations

US(1)