Safety and Efficacy of CryoCor™ Cryoablation for PAF - Full Text View

Sponsored by:	CryoCor
Information provided by:	CryoCor
ClinicalTrials.gov Identifier:	NCT00231296

Purpose

A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF

Condition	Intervention	Phase
Atrial Fibrillation	Device: Cardiac cryoablation system Drug: Medical management	Phase III

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation

Further study details as provided by CryoCor:

Primary Outcome Measures:

Safety profile of intervention [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Recurrence of PAF [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	174
Study Start Date:	November 2004
Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Active Comparator Treatment with CryoCor Cryoablation System	Device: Cardiac cryoablation system Treatment with CryoCor cardiac cryoablation system
2: Active Comparator Treatment with standard medical therapy	Drug: Medical management Treatment with standard medical therapy

Detailed Description:

The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.

Eligibility

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

Criteria

Inclusion Criteria:

At least 3 episodes of PAF within 6 months
Refractory to at least one drug
Therapeutic anticoagulation
Signed informed consent

Exclusion Criteria:

Persistent AF
Structural heart disease
Prior ablation
Contraindication present

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231296

Locations

United States, California
University of California at San Diego Medical Center
San Diego, California, United States, 92103

Sponsors and Collaborators

CryoCor

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	CryoCor, Inc.
Study ID Numbers:	GL-AF-02
Study First Received:	September 30, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00231296
Health Authority:	United States: Food and Drug Administration

Keywords provided by CryoCor:

cryoablation
atrial fibrillation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009