Status:
COMPLETED
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 typi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00318565
Start Date
January 1 2006
End Date
February 1 2008
Last Update
March 5 2012
Active Locations (23)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251
3
Good Samaritan Hospital
Los Angeles, California, United States, 90017
4
Pacific Heart Institute
Santa Monica, California, United States, 90404