Safety and Efficacy of CryoCor™ Cryoablation for PAF

A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231296

Enrollment

174

Registered

2005-10-04

Start date

2004-11-30

Completion date

2009-03-31

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

cryoablation, atrial fibrillation

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.

Interventions

DEVICECardiac CryoCor Cryoablation System

Treatment with CryoCor Cardiac Cryoablation system

DRUGMedical management

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety profile of intervention	12 months
Recurrence of PAF	12 months

Secondary

Measure	Time frame	Description
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 QOL as measured by SF-36 Health Survey	12 months	Changes compared to baseline will be measured over a period of 12 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.
Change in luminal PV measurements	6 months	—
Change in QOL as measured by Symptom Checklist	12 months	Changes compared to baseline will be measured over a period of 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026