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

Primary Purpose

Cavotricuspid Isthmus Dependent Right Atrial Flutter

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Endocardial Ablation

About this trial

This is an interventional treatment trial for Cavotricuspid Isthmus Dependent Right Atrial Flutter focused on measuring Endocardial Ablation, Atrial Flutter, Cavotricuspid Isthmus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Miulli Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endocardial Ablation

Arm Description

Outcomes

Primary Outcome Measures

Safety

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

Acute performance

Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)

Secondary Outcome Measures

Safety

Incidence of Serious Adverse Events during follow-up

Acute Efficacy

Right atrial flutter recurrence within 30 days

Procedural data

Ablation parameters, including: Total RF ablation time Temperature Contact Force Procedural time Total fluoroscopy time

Full Information

NCT ID

NCT02257060

First Posted

September 2, 2014

Last Updated

June 24, 2015

Sponsor

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02257060

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosense Webster, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cavotricuspid Isthmus Dependent Right Atrial Flutter

Keywords

Endocardial Ablation, Atrial Flutter, Cavotricuspid Isthmus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endocardial Ablation

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Endocardial Ablation

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Safety

Description

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

Time Frame

7 Days

Title

Acute performance

Description

Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)

Time Frame

This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation

Secondary Outcome Measure Information:

Title

Safety

Description

Incidence of Serious Adverse Events during follow-up

Time Frame

Until one-month follow-up

Title

Acute Efficacy

Description

Right atrial flutter recurrence within 30 days

Time Frame

Within 30 Days

Title

Procedural data

Description

Ablation parameters, including: Total RF ablation time Temperature Contact Force Procedural time Total fluoroscopy time

Time Frame

During Procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massimo Grimaldi

Organizational Affiliation

Miulli Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miulli Hospital

City

Acquaviva Delle Fonti

State/Province

Bari/Strada

ZIP/Postal Code

70021

Country

Italy

12. IPD Sharing Statement

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

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