Safety and Efficacy of CryoCor™ Cryoablation for PAF

May 2, 2017 updated by: Boston Scientific Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95819
        • Regional Cardiology Associates
      • San Diego, California, United States, 92103
        • UCSD Medical Center
      • San Francisco, California, United States, 94143
        • UCSF Medical
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
      • Urbana, Illinois, United States, 61801
        • Carle Heart Center
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Health
      • Des Moines, Iowa, United States, 50309
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Cardiology Associates of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
    • New York
      • New York, New York, United States, 10025
        • St. Luke's-Roosevelt Hospital Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Heart and Vascular Institute
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart, PA
      • Houston, Texas, United States, 77030
        • Methodist DeBakey Heart Center
    • Washington
      • Tacoma, Washington, United States, 98415
        • Tacoma General
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Heart Care Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment with CryoCor Cryoablation System
Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
Device: Cardiac CryoCor Cryoablation System
Treatment with CryoCor Cardiac Cryoablation system
Other Names:
  • Ablation with the CryoCor ablation catheter
Active Comparator: Treatment with standard medical therapy
Intervention includes treatment with ant-arrhythmic medications alone.
Drug: Medical management
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Other Names:
  • AAD treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile of intervention
Time Frame: 12 months
12 months
Recurrence of PAF
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months
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
12 months
Change in luminal PV measurements
Time Frame: 6 months
6 months
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.
Post resolution period (12 months follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Gregory Feld, MD, University of California, San Diego (UCSD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2004

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL-AF-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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