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

This study has been completed.
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: August 20, 2014
Last verified: August 2014
  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:


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
Study Completion Date: July 2014
Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173809

Locations
United States, Texas
St.David's Medical Center
Austin, Texas, United States, 78705
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 TCAI, St.David's Medical Center
Principal Investigator: Luigi Di Biase, Md, PhD Texas Cardiac Arrhythmia Research Foundation
  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: August 20, 2014
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 September 16, 2014