Safety and Efficacy of CryoCor™ Cryoablation for PAF

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231296
• Other study ID #: GL-AF-02
• Status: Completed
• Phase: N/A
• First received: September 30, 2005
• Last updated: May 2, 2017
• Start date: November 2004
• Est. completion date: March 2009

Study information

• Verified date: May 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Cardiac CryoCor Cryoablation System
Treatment with CryoCor Cardiac Cryoablation system

Drug:
• Medical management
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Austin Heart, PA	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Chicago Hospitals	Chicago	Illinois
United States	Genesis Health	Davenport	Iowa
United States	Iowa Heart Center	Des Moines	Iowa
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	University of Florida	Gainesville	Florida
United States	Penn State Heart and Vascular Institute	Hershey	Pennsylvania
United States	Methodist Debakey Heart Center	Houston	Texas
United States	Cardiology Associates of Kentucky	Lexington	Kentucky
United States	Heart Care Associates	Milwaukee	Wisconsin
United States	St. Luke's-Roosevelt Hospital Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Drexel University	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Regional Cardiology Associates	Sacramento	California
United States	UCSD Medical Center	San Diego	California
United States	UCSF Medical	San Francisco	California
United States	Tacoma General	Tacoma	Washington
United States	University of South Florida	Tampa	Florida
United States	Carle Heart Center	Urbana	Illinois
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of intervention		12 months
Primary	Recurrence of PAF		12 months
Secondary	Change in QOL as measured by SF-36 Health Survey	Changes compared to baseline will be measured over a period of 12 months	12 months
Secondary	Change in QOL as measured by Symptom Checklist	Changes compared to baseline will be measured over a period of 12 months	12 months
Secondary	Change in QOL as measured by Arrhythmia Severity scale	Changes compared to baseline will be measured over a period of 12 months	12 months
Secondary	Change in luminal PV measurements		6 months
Secondary	Time to treatment failure, post resolution period	Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.	Post resolution period (12 months follow-up)