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

Biosense Webster

Status and phase: Completed; Phase 1

Conditions: Cavotricuspid Isthmus Dependent Right Atrial Flutter

Treatments: Procedure: Endocardial Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02257060

LINEAR II

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Endocardial Ablation

Experimental group

Treatment:

Procedure: Endocardial Ablation