Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

NCT00318565 | Completed Phase 4 Results

• 1 other identifier: BWI30031
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 23

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).

Conditions

Atrial Flutter

Keywords

Heart Disease; Atrial Flutter; Typical Atrial Flutter

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Navistar ThermoCool Catheter

EXPERIMENTAL

Device: RF energy delivery for treatment of Typical Atrial flutter

Interventions

RF energy delivery for treatment of Typical Atrial flutter DEVICE

Navistar ThermoCool catheter

Also known as: Therapeutic Catheters

Navistar ThermoCool Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (23)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

University of Florida

Gainsville, Florida, 32611, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33031, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.

Indianapolis, Indiana, 46060, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Park Nicollet Institute

Minneapolis, Minnesota, 55416, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Oklahoma, Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Vermont, College of Medicine

Burlington, Vermont, 05401, United States

Location

INOVA Research Center

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Atrial Flutter; Heart Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christine Liu
• Organization: Biosense Webster

cliu10@its.jnj.com

9098398608

Study Officials

• Warren Jackman, M.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: January 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: February 1, 2008
• Last Updated: March 5, 2012
• Results First Posted: March 2, 2010

Record last verified: 2012-03

Locations

US (23)