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Safety and Efficacy of CryoCor™ Cryoablation for PAF

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac CryoCor Cryoablation System
Medical management
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring cryoablation, atrial fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Regional Cardiology Associates
  • UCSD Medical Center
  • UCSF Medical
  • University of Florida
  • University of South Florida
  • Emory University
  • University of Chicago Hospitals
  • Carle Heart Center
  • Genesis Health
  • Iowa Heart Center
  • Cardiology Associates of Kentucky
  • Johns Hopkins Hospital
  • University of Nebraska Medical Center
  • Englewood Hospital and Medical Center
  • St. Luke's-Roosevelt Hospital Center
  • University of Rochester Medical Center
  • Wake Forest University Health Sciences
  • Oregon Health and Science University
  • Penn State Heart and Vascular Institute
  • Drexel University
  • Austin Heart, PA
  • Methodist Debakey Heart Center
  • Tacoma General
  • Heart Care Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment with CryoCor Cryoablation System

Treatment with standard medical therapy

Arm Description

Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.

Intervention includes treatment with ant-arrhythmic medications alone.

Outcomes

Primary Outcome Measures

Safety profile of intervention
Recurrence of PAF

Secondary Outcome Measures

Change in QOL as measured by SF-36 Health Survey
Changes compared to baseline will be measured over a period of 12 months
Change in QOL as measured by Symptom Checklist
Changes compared to baseline will be measured over a period of 12 months
Change in QOL as measured by Arrhythmia Severity scale
Changes compared to baseline will be measured over a period of 12 months
Change in luminal PV measurements
Time to treatment failure, post resolution period
Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.

Full Information

First Posted
September 30, 2005
Last Updated
May 2, 2017
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00231296
Brief Title
Safety and Efficacy of CryoCor™ Cryoablation for PAF
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
cryoablation, atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with CryoCor Cryoablation System
Arm Type
Active Comparator
Arm Description
Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
Arm Title
Treatment with standard medical therapy
Arm Type
Active Comparator
Arm Description
Intervention includes treatment with ant-arrhythmic medications alone.
Intervention Type
Device
Intervention Name(s)
Cardiac CryoCor Cryoablation System
Other Intervention Name(s)
Ablation with the CryoCor ablation catheter
Intervention Description
Treatment with CryoCor Cardiac Cryoablation system
Intervention Type
Drug
Intervention Name(s)
Medical management
Other Intervention Name(s)
AAD treatment
Intervention Description
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Primary Outcome Measure Information:
Title
Safety profile of intervention
Time Frame
12 months
Title
Recurrence of PAF
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in QOL as measured by SF-36 Health Survey
Description
Changes compared to baseline will be measured over a period of 12 months
Time Frame
12 months
Title
Change in QOL as measured by Symptom Checklist
Description
Changes compared to baseline will be measured over a period of 12 months
Time Frame
12 months
Title
Change in QOL as measured by Arrhythmia Severity scale
Description
Changes compared to baseline will be measured over a period of 12 months
Time Frame
12 months
Title
Change in luminal PV measurements
Time Frame
6 months
Title
Time to treatment failure, post resolution period
Description
Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period.
Time Frame
Post resolution period (12 months follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Feld, MD
Organizational Affiliation
University of California, San Diego (UCSD)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Cardiology Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF Medical
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Carle Heart Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Genesis Health
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Cardiology Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Heart and Vascular Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Austin Heart, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Methodist Debakey Heart Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Tacoma General
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415
Country
United States
Facility Name
Heart Care Associates
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of CryoCor™ Cryoablation for PAF

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