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OpenTrials
Completed

NCT Number: NCT00231296

Safety and Efficacy of CryoCor™ Cryoablation for PAF

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Cardiology Associates, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac CryoCor Cryoablation System

Device

Treatment with CryoCor Cardiac Cryoablation system

Other names: Ablation with the CryoCor ablation catheter

Medical Management

Drug

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

Other names: AAD treatment

Primary outcomes

  1. Safety profile of intervention

    Time frame: 12 months

  2. Recurrence of PAF

    Time frame: 12 months

Secondary outcomes

  1. Change in QOL as measured by SF-36 Health Survey

    Time frame: 12 months

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

  2. Change in QOL as measured by Symptom Checklist

    Time frame: 12 months

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

  3. Change in QOL as measured by Arrhythmia Severity scale

    Time frame: 12 months

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

  4. Change in luminal PV measurements

    Time frame: 6 months

  5. Time to treatment failure, post resolution period

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

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 4, 2005
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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