NCT01206452

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2010

Typical duration 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

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

April 1, 2017

Enrollment Period

3.3 years

First QC Date

September 20, 2010

Results QC Date

January 25, 2016

Last Update Submit

April 11, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Ablation

Outcome Measures

Primary Outcomes (1)

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

    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.

    From 6 months up to 12 months post-procedure

Secondary Outcomes (4)

  • 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 Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months

    From 3 months up to 6 months post-procedure

  • Inflammatory Cytokine Response to Ablation Procedure

    Immediately Post-Ablation Procedure

  • Inflammatory Cytokine Response to Ablation Procedure

    24 Hours after Ablation Procedure

Study Arms (2)

Ablation plus prednisone

EXPERIMENTAL

Participants undergo ablation procedure and receive predinisone at protocol determined times.

Drug: PrednisoneProcedure: Ablation Procedure

Ablation plus placebo

PLACEBO COMPARATOR

Participants undergo ablation procedure and receive placebo at protocol determined times.

Other: PlaceboProcedure: Ablation Procedure

Interventions

PrednisoneDRUG

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

Ablation plus prednisone
PlaceboOTHER

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

Ablation plus placebo
Ablation ProcedurePROCEDURE

Atrial Fibrillation (AF) ablation

Ablation plus placeboAblation plus prednisone

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Donita Atkins, RN, CCRC
Organization
University of Kansas Medical Center
datkins2@kumc.edu
(913) 588-9714

Study Officials

  • Dhanunjaya Lakkireddy, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 17, 2017

Results First Posted

May 17, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)