Safety and Efficacy of CryoCor™ Cryoablation for PAF

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Medical management; Device: Cardiac CryoCor Cryoablation System

• Registration Number: NCT00231296
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with standard medical therapy	Medical management	Intervention includes treatment with ant-arrhythmic medications alone.
Treatment with CryoCor Cryoablation System	Cardiac CryoCor Cryoablation System	Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.

Primary Outcome Measures

Name	Time	Method
Safety profile of intervention	12 months
Recurrence of PAF	12 months

Secondary Outcome Measures

Name	Time	Method
Change in QOL as measured by Symptom Checklist	12 months	Changes compared to baseline will be measured over a period of 12 months
Change in QOL as measured by SF-36 Health Survey	12 months	Changes compared to baseline will be measured over a period of 12 months
Change in QOL as measured by Arrhythmia Severity scale	12 months	Changes compared to baseline will be measured over a period of 12 months
Change in luminal PV measurements	6 months
Time to treatment failure, post resolution period	Post resolution period (12 months follow-up)	Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.

Trial Locations

Locations (24)

Regional Cardiology Associates; 🇺🇸 Sacramento, California, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

UCSF Medical; 🇺🇸 San Francisco, California, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Chicago Hospitals; 🇺🇸 Chicago, Illinois, United States

Carle Heart Center; 🇺🇸 Urbana, Illinois, United States

Genesis Health; 🇺🇸 Davenport, Iowa, United States

Iowa Heart Center; 🇺🇸 Des Moines, Iowa, United States

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