Safety and Efficacy of CryoCor™ Cryoablation for PAF

Boston Scientific Corporation174 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

174

Conditions

Atrial Fibrillation

Interventions

Cardiac CryoCor Cryoablation SystemDEVICE

Treatment with CryoCor Cardiac Cryoablation system

Medical managementDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (24)

Regional Cardiology Associates

Sacramento, California, United States

Outcomes

Primary Outcomes

Safety profile of intervention

Time frame: 12 months

Recurrence of PAF

Time frame: 12 months

Secondary Outcomes

Change in QOL as measured by SF-36 Health Survey

Changes compared to baseline will be measured over a period of 12 months

Time frame: 12 months

Change in QOL as measured by Symptom Checklist

Changes compared to baseline will be measured over a period of 12 months

Time frame: 12 months

Change in QOL as measured by Arrhythmia Severity scale

Changes compared to baseline will be measured over a period of 12 months

Time frame: 12 months

Change in luminal PV measurements

Time frame: 6 months

Time to treatment failure, post resolution period

Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.

Time frame: Post resolution period (12 months follow-up)

Data from ClinicalTrials.gov

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