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Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation (SPECULATE)

This study is currently recruiting participants.
Verified November 2010 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborators:
University of Kansas
California Pacific Medical Center
Stanford University
Case Western Reserve University
Southlake Regional Health Centre
Catholic University, Italy
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01173809
First received: July 29, 2010
Last updated: May 31, 2012
Last verified: November 2010
History of Changes
  Purpose

This prospective randomized study aims to investigate the effect of continuous versus interrupted use of Amiodarone on the procedure outcome in long-standing persistent (LSP) atrial fibrillation patients undergoing pulmonary vein antral isolation (PVAI).


Condition Intervention Phase
Atrial Fibrillation
 Drug: Amiodarone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Recurrence of atrial arrhythmia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Recurrence of AF, atrial flutter or atrial tachycardia


Secondary Outcome Measures:
  • Relapse of AF [ Time Frame: 1 yeay ] [ Designated as safety issue: No ]
    Difference in the occurrence of relapse between the control and the study groups


Estimated Enrollment: 176
Study Start Date: October 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Patient will continue taking Amiodarone before, during and after catheter ablation (8 weeks post-ablation).
 Drug: Amiodarone
Patient will continue taking Amiodarone before, during and after ablation (8 weeks post-ablation).
Active Comparator: Study
Amiodarone therapy will be stopped at least 5-months before ablation procedure and ablation will be performed off Amiodarone. Patients will not take Amiodarone during the blanking period (8 weeks post-ablation).
 Drug: Amiodarone
Amiodarone therapy will be stopped at least 5-months before ablation procedure and ablation will be performed off Amiodarone. Patients will not take Amiodarone during the blanking period (8 weeks post-ablation).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of LSP AF
  2. Age > 18 years
  3. Willing and ability to understand and sign an informed consent
  4. Patients on chronic Amiodarone therapy (≥ 3 months)

Exclusion Criteria:

  1. Unstable angina
  2. Concomitant treatment with other class I or III antiarrhythmic drugs
  3. Myocardial infarction within past 3 months)
  4. Presence of any disease that is likely to shorten life expectancy to < 1 year
  5. Symptomatic heart failure, NYHA III or IV
  6. Contraindications for Amiodarone
  7. Chronic liver diseases
  8. Pregnant or breast-feeding mothers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173809

Contacts
Contact: Luigi Di Biase, MD 512-423-9855 dibbia@gmail.com
Contact: Mitra Mohanty, MD 512-544-8198 mitra.mohanty@stdavids.com

Locations
United States, Texas
St.David's Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Luigi Di Biase, MD     512-423-9855     dibbia@gmail.com    
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
University of Kansas
California Pacific Medical Center
Stanford University
Case Western Reserve University
Southlake Regional Health Centre
Catholic University, Italy
Investigators
Principal Investigator: Andrea Natale, MD, FACC, FHRS TCAI, St.David's Medical Center
  More Information

No publications provided

Responsible Party: Andrea Natale, Medical director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01173809     History of Changes
Other Study ID Numbers: TCAI-SPECULATE
Study First Received: July 29, 2010
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
AF
Catheter Ablation
Recurrence of AF
Amiodarone

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 22, 2013