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Efficacy of Pilsicainide After Radiofrequency Ablation of Paroxysmal Atrial Fibrillation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Young-Hoon Kim, Korea University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775891
First Posted: January 25, 2013
Last Update Posted: February 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Young-Hoon Kim, Korea University
  Purpose
Investigators hypothesized that the use of Pilsicainide after radiofrequency ablation of AF could reduce the incidence of recurrence of atrial arrhythmia during follow up compared with other class IC antiarrhythmic drugs.

Condition Intervention
Paroxysmal Atrial Fibrillation Drug: pilsicainide Drug: other class IC antiarrhythmic drug

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Pilsicainide After Radiofrequency Ablation of Paroxysmal Atrial Fibrillation Compared With Other Class IC Anti-arrhythmic Drugs

Resource links provided by NLM:


Further study details as provided by Young-Hoon Kim, Korea University:

Primary Outcome Measures:
  • freedom from recurrence of any atrial arrhythmia within 1 year [ Time Frame: 1 year ]

Estimated Enrollment: 245
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pilsicainide
The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Drug: pilsicainide
The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: Pilsicainide (Sunrhythm®) Daiichi Sankyo
Drug: other class IC antiarrhythmic drug
Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: flecainide 100mg bid PO or propafenone 225mg tid
Placebo Comparator: other class IC antiarrhythmic drug
Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Drug: pilsicainide
The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: Pilsicainide (Sunrhythm®) Daiichi Sankyo
Drug: other class IC antiarrhythmic drug
Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
Other Name: flecainide 100mg bid PO or propafenone 225mg tid

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with drug-refractory paroxysmal atrial fibrillation who requires catheter ablation
  • patients who are aged 18-80 and agree with this study

Exclusion Criteria:

  • patients who do not agree with this study
  • patients with a history of catheter ablatio or surgery for atrial fibrillation
  • patients who experienced side effects of pilsicainide before
  • patients who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • patients who has congestive heart failure with ejection fraction<40% or decompensated heart failure
  • patients with significant coronary artery disease, liver/renal disease
  • patients who has other kinds of arrhythmic which requires active treatment
  • contraindication to warfarin therapy
  • life expectancy <1 year]
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775891


Contacts
Contact: Young-Hoon Kim, M.D., PhD. +82-10-9370-3337 ypruimin@naver.com
Contact: Yae Min Park, M.D. +82-10-9370-3337 ypruimin@naver.com

Locations
Korea, Republic of
Arrhythmia center, Anam Hospital, Korea University Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Young-Hoon Kim, M.D. PhD.    +82-10-9370-3337    ypruimin@naver.com   
Contact: Yae Min Park, M.D.    +82-10-9370-3337    ypruimin@naver.com   
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Young-Hoon Kim, MD., PhD Arrhythmia center, Anam hospital, Korea university
  More Information

Responsible Party: Young-Hoon Kim, M.D. PhD, Korea University
ClinicalTrials.gov Identifier: NCT01775891     History of Changes
Other Study ID Numbers: PIL245
First Submitted: January 23, 2013
First Posted: January 25, 2013
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Young-Hoon Kim, Korea University:
pilsicainide
class IC antiarrhythmic drug
paroxysmal atrial fibrillation
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pilsicainide
Anti-Arrhythmia Agents
Flecainide
Propafenone
Lidocaine
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents