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

Phase 1

Completed

• Conditions: Cavotricuspid Isthmus Dependent Right Atrial Flutter
• Interventions: Procedure: Endocardial Ablation

• Registration Number: NCT02257060
• Lead Sponsor: Biosense Webster, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-06
• Primary Completion: 2014-11
• Study Completion: 2015-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endocardial Ablation	Endocardial Ablation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Miulli Hospital; 🇮🇹 Acquaviva Delle Fonti, Bari/Strada, Italy