Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter

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).

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Device: RF energy delivery for treatment of Typical Atrial flutter

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.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama, Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Arizona Arrhythmia Consultants
  • California
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Santa Monica, California, United States, 90404
      • Pacific Heart Institute
  • Florida
    • Gainsville, Florida, United States, 32611
      • University of Florida
    • Hollywood, Florida, United States, 33031
      • Memorial Regional Hospital
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46060
      • The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Park Nicollet Institute
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma, Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Heart Institute
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont, College of Medicine
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Research Center
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navistar ThermoCool Catheter	Device: RF energy delivery for treatment of Typical Atrial flutter; Navistar ThermoCool catheter; Other Names: Therapeutic Catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure
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.	7 Days

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Warren Jackman, M.D., University of Oklahoma

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: April 25, 2006
• First Submitted That Met QC Criteria: April 25, 2006
• First Posted (Estimate): April 27, 2006

Study Record Updates

• Last Update Posted (Estimate): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Heart Disease; Atrial Flutter; Typical Atrial Flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: BWI30031