Effect of Amiodarone on the Procedure Outcome in Long-standing Persistent Atrial Fibrillation Undergoing Pulmonary Vein Antral Isolation - Full Text View

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

First Received on July 29, 2010. Last Updated on November 2, 2010 History of Changes

Sponsor:	Texas Cardiac Arrhythmia Research Foundation
Collaborators:	University of Kansas California Pacific Medical Center Stanford University Case Western Reserve University Southlake Regional Health Centre Catholic University, Italy
Information provided by:	Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:	NCT01173809

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

Drug Information available for: Amiodarone Amiodarone hydrochloride

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:	May 2012
Estimated Primary Completion Date:	November 2011 (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).

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Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unstable angina
Concomitant treatment with other class I or III antiarrhythmic drugs
Myocardial infarction within past 3 months)
Presence of any disease that is likely to shorten life expectancy to < 1 year
Symptomatic heart failure, NYHA III or IV
Contraindications for Amiodarone
Chronic liver diseases
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, MD, FACC, FHRS; Executive Medical Director of the Texas Cardiac Arrhythmia Institute, Texas Cardiac Arrhythmia Institute, St.David's Medical Center, Austin, Texas
ClinicalTrials.gov Identifier:	NCT01173809 History of Changes
Other Study ID Numbers:	TCAI-SPECULATE
Study First Received:	July 29, 2010
Last Updated:	November 2, 2010
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 23, 2012