Clinical trial NCT00231296: Safety and Efficacy of CryoCor™ Cryoablation for PAF
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: cryoablation
atrial fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Safety profile of intervention
timeFrame: 12 months
measure: Recurrence of PAF
timeFrame: 12 months
Secondary outcomes:
measure: Change in QOL as measured by SF-36 Health Survey
timeFrame: 12 months
measure: Change in QOL as measured by Symptom Checklist
timeFrame: 12 months
measure: Change in QOL as measured by Arrhythmia Severity scale
timeFrame: 12 months
measure: Change in luminal PV measurements
timeFrame: 6 months
measure: Time to treatment failure, post resolution period
timeFrame: Post resolution period (12 months follow-up)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Urbana
country: United States
facility: Carle Heart Center
state: Illinois
city: Davenport
country: United States
facility: Genesis Health
state: Iowa
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: Cardiology Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Heart and Vascular Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart, PA
state: Texas
city: Houston
country: United States
facility: Methodist Debakey Heart Center
state: Texas
city: Tacoma
country: United States
facility: Tacoma General
state: Washington
city: Milwaukee
country: United States
facility: Heart Care Associates
state: Wisconsin
Study officials:
affiliation: University of California, San Diego
name: Gregory Feld, MD
role: PRINCIPAL_INVESTIGATOR
References: