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Safety and Efficacy of CryoCor™ Cryoablation for PAF

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00231296
Collaborator
(none)
174
Enrollment
24
Locations
2
Arms
51.9
Actual Duration (Months)
7.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Cardiac CryoCor Cryoablation System
  • Drug: Medical management
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
Actual Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety profile of intervention [12 months]

    2. Recurrence of PAF [12 months]

    Secondary Outcome Measures

    1. 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

    2. Change in QOL as measured by Symptom Checklist [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 [12 months]

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

    4. Change in luminal PV measurements [6 months]

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regional Cardiology Associates Sacramento California United States 95819
    2 UCSD Medical Center San Diego California United States 92103
    3 UCSF Medical San Francisco California United States 94143
    4 University of Florida Gainesville Florida United States 32611
    5 University of South Florida Tampa Florida United States 33606
    6 Emory University Atlanta Georgia United States 30308
    7 University of Chicago Hospitals Chicago Illinois United States 60637
    8 Carle Heart Center Urbana Illinois United States 61801
    9 Genesis Health Davenport Iowa United States 52803
    10 Iowa Heart Center Des Moines Iowa United States 50309
    11 Cardiology Associates of Kentucky Lexington Kentucky United States 40504
    12 Johns Hopkins Hospital Baltimore Maryland United States 21287
    13 University of Nebraska Medical Center Omaha Nebraska United States 68198
    14 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
    15 St. Luke's-Roosevelt Hospital Center New York New York United States 10025
    16 University of Rochester Medical Center Rochester New York United States 14642
    17 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    18 Oregon Health and Science University Portland Oregon United States 97239
    19 Penn State Heart and Vascular Institute Hershey Pennsylvania United States 17033
    20 Drexel University Philadelphia Pennsylvania United States 19102
    21 Austin Heart, PA Austin Texas United States 78756
    22 Methodist Debakey Heart Center Houston Texas United States 77030
    23 Tacoma General Tacoma Washington United States 98415
    24 Heart Care Associates Milwaukee Wisconsin United States 53215

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT00231296
    Other Study ID Numbers:
    • GL-AF-02
    First Posted:
    Oct 4, 2005
    Last Update Posted:
    May 4, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Boston Scientific Corporation
    cryoablation
    atrial fibrillation
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 4, 2017