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

NCT02257060 | Completed Phase 1

• 1 other identifier: LINEAR II
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

Endocardial Ablation; Atrial Flutter; Cavotricuspid Isthmus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Safety

  Until one-month follow-up

• Acute Efficacy

  Within 30 Days

• Procedural data

  During Procedure

Study Arms (1)

Endocardial Ablation

EXPERIMENTAL

Procedure: Endocardial Ablation

Interventions

Endocardial Ablation PROCEDURE

Also known as: Radiofrequency (RF) ablation with the, - Linear Type Ablation Catheter, - nMARQ™ Multi-Channel RF Generator with Software V2.4.0, - Linear Ablation Connection Cable

Endocardial Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Grimaldi

  Miulli Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: October 6, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: February 3, 2025

Record last verified: 2025-01