Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: RF energy delivery for treatment of Typical Atrial flutter


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navistar ThermoCool Catheter<br> | Device: RF energy delivery for treatment of Typical Atrial flutter<br>* Navistar ThermoCool catheter<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Disease, Atrial Flutter, Typical Atrial Flutter