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

NCT ID: NCT02257060

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

Brief Summary

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.

Conditions

Cavotricuspid Isthmus Dependent Right Atrial Flutter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endocardial Ablation

Group Type: EXPERIMENTAL

Endocardial Ablation

Intervention Type: PROCEDURE

Interventions

Endocardial Ablation

Intervention Type: PROCEDURE

Other Intervention Names

Radiofrequency (RF) ablation with the; - Linear Type Ablation Catheter; - nMARQ™ Multi-Channel RF Generator with Software V2.4.0; - Linear Ablation Connection Cable

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Grimaldi

Role: PRINCIPAL_INVESTIGATOR

Miulli Hospital

Other Identifiers

LINEAR II

Identifier Type: -

Identifier Source: org_study_id