Clinical trial NCT00318565: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Flutter
Keywords: Heart Disease
Atrial Flutter
Typical Atrial Flutter
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Subjects With Complete Bidirectional Conduction Block.
timeFrame: During the procedure
measure: Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
state: Indiana
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma, Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Burlington
country: United States
facility: University of Vermont, College of Medicine
state: Vermont
city: Falls Church
country: United States
facility: INOVA Research Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Oklahoma
name: Warren Jackman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: