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Completed

NCT Number: NCT02257060

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

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.

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Key information

Conditions

Cavotricuspid Isthmus Dependent Right Atrial Flutter Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocardial Ablation

Procedure

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

Primary outcomes

  1. Safety

    Time frame: 7 Days

    Incidence of early onset (within 7 days of ablation procedure) primary AEs

  2. Acute performance

    Time frame: 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 outcomes

  1. Safety

    Time frame: Until one-month follow-up

    Incidence of Serious Adverse Events during follow-up

  2. Acute Efficacy

    Time frame: Within 30 Days

    Right atrial flutter recurrence within 30 days

  3. Procedural data

    Time frame: During Procedure

    Ablation parameters, including:

    • Total RF ablation time
    • Temperature
    • Contact Force Procedural time Total fluoroscopy time

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Oct 6, 2014
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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