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Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
RF energy delivery for treatment of Typical Atrial flutter
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring Heart Disease, Atrial Flutter, Typical Atrial Flutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation. At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment. 18 years of age or older Informed consent Exclusion Criteria: Intracardiac thrombus Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure Women who are pregnant Cardiac surgery (ventriculotomy or atriotomy) within the past two months Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement Unstable angina or acute myocardial infarction within 3 months Awaiting cardiac transplantation Heart disease in which corrective surgery is anticipated within 6 months Presence of condition that precludes appropriate vascular access Enrolled in any investigational device exemption (IDE) investigating study for a device or drug High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician) Radio frequency (RF) ablation for typical atrial flutter within the past 2 months

Sites / Locations

  • University of Alabama, Birmingham
  • Arizona Arrhythmia Consultants
  • Good Samaritan Hospital
  • Pacific Heart Institute
  • University of Florida
  • Memorial Regional Hospital
  • Florida Hospital
  • University of Chicago
  • The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
  • Central Baptist Hospital
  • Maine Medical Center
  • University of Maryland
  • Massachusetts General Hospital
  • St. John Hospital and Medical Center
  • Park Nicollet Institute
  • Duke University Medical Center
  • University of Oklahoma, Health Sciences Center
  • University of Pennsylvania
  • Medical University of South Carolina
  • Texas Heart Institute
  • University of Vermont, College of Medicine
  • INOVA Research Center
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Navistar ThermoCool Catheter

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Subjects With Complete Bidirectional Conduction Block.
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2006
Last Updated
March 1, 2012
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00318565
Brief Title
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
Official Title
Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Detailed Description
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Heart Disease, Atrial Flutter, Typical Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navistar ThermoCool Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RF energy delivery for treatment of Typical Atrial flutter
Other Intervention Name(s)
Therapeutic Catheters
Intervention Description
Navistar ThermoCool catheter
Primary Outcome Measure Information:
Title
Percentage of Subjects With Complete Bidirectional Conduction Block.
Description
Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.
Time Frame
During the procedure
Title
Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
Description
The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation. At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment. 18 years of age or older Informed consent Exclusion Criteria: Intracardiac thrombus Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure Women who are pregnant Cardiac surgery (ventriculotomy or atriotomy) within the past two months Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement Unstable angina or acute myocardial infarction within 3 months Awaiting cardiac transplantation Heart disease in which corrective surgery is anticipated within 6 months Presence of condition that precludes appropriate vascular access Enrolled in any investigational device exemption (IDE) investigating study for a device or drug High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician) Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Jackman, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Florida
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33031
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Park Nicollet Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Oklahoma, Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont, College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
INOVA Research Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

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Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

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