LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter

Study Overview
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Brief Summary
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The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.

Official Title
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Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter

Conditions
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Cavotricuspid Isthmus Dependent Right Atrial Flutter

Intervention / Treatment
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* Procedure: Endocardial Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device. Age 18 years or older. Exclusion Criteria: Previous typical CTI dependent right atrial flutter ablation Uncontrolled heart failure or NYHA function class IV MI within the past 2 months Any cardiac surgery (i.e. CABG) within the past 2 months Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) Awaiting cardiac transplantation or other cardiac surgery within the next 6 months Documented thromboembolic event (including TIA) within the past 12 months Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study Active illness or active systemic infection or sepsis Unstable angina History of blood clotting or bleeding abnormalities Contraindication to anticoagulation (eg, heparin or warfarin) Life expectancy less than 6 months Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation Presence of a condition that precludes vascular access Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation Currently enrolled in another device, biologics, or drug study Contraindication for use of the investigational catheter, as indicated in the respective Instructions For Use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocardial Ablation<br> | Procedure: Endocardial Ablation<br> <br> * Other names: - Linear Ablation Connection Cable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Incidence of early onset (within 7 days of ablation procedure) primary AEs | 7 Days | 
| Acute performance | Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application) | This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Incidence of Serious Adverse Events during follow-up | Until one-month follow-up | 
| Acute Efficacy | Right atrial flutter recurrence within 30 days | Within 30 Days | 
| Procedural data | Ablation parameters, including: Total RF ablation time Temperature Contact Force Procedural time Total fluoroscopy time | During Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endocardial Ablation, Atrial Flutter, Cavotricuspid Isthmus