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

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

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.

Study Overview

• Status: Completed
• Conditions: Cavotricuspid Isthmus Dependent Right Atrial Flutter
• Intervention / Treatment: Procedure: Endocardial Ablation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Italy
  • Bari/Strada
    • Acquaviva Delle Fonti, Bari/Strada, Italy, 70021
      • Miulli Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endocardial Ablation	Procedure: Endocardial Ablation; Other Names: Radiofrequency (RF) ablation with the; - Linear Type Ablation Catheter; - nMARQ™ Multi-Channel RF Generator with Software V2.4.0; - Linear Ablation Connection Cable

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Massimo Grimaldi, Miulli Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: October 2, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Atrial Flutter; Endocardial Ablation; Cavotricuspid Isthmus
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: LINEAR II