Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Biosense Webster

Status and phase: Completed; Phase 4

Conditions: Atrial Flutter

Treatments: Device: RF energy delivery for treatment of Typical Atrial flutter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00318565

BWI30031

Details and patient eligibility

About

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).

Full 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.

Enrollment: 291 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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291 participants in 1 patient group

Navistar ThermoCool Catheter

Experimental group

Treatment:

Device: RF energy delivery for treatment of Typical Atrial flutter