Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)

Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)

The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Endocardial Ablation Procedure

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sant'Eramo, Italy
    • Ospedale Generale Regionale "F. Miulli"
  • Torino, Italy, 10126
    • Ospedale San Giovanni Battista Molinette
• United Kingdom
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield Hospital
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital London

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age > 18 years.
2. Signed the Patient Informed Consent Form (ICF)
3. Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days)
4. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

1. Previous surgical or catheter ablation for atrial fibrillation
2. Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
3. Any carotid stenting or endarterectomy
4. Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
5. LA size > 55 mm
6. LVEF <40%
7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
8. Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
9. Uncontrolled heart failure or NYHA function class III and IV
10. MI within the past 2 months
11. Any cardiac surgery (i.e. CABG) within the past 2 months
12. Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
13. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
14. Documented thromboembolic event (including TIA) within the past 12 months
15. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
16. Active illness or active systemic infection or sepsis
17. Unstable angina
18. History of blood clotting or bleeding abnormalities
19. Contraindication to anticoagulation (eg, heparin or warfarin)
20. Life expectancy less than 12 months
21. Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
22. Presence of a condition that precludes vascular access
23. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
24. Currently enrolled in another device, biologics, or drug study
25. Contraindication for use of the investigational devices , 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; ablation with Linear type catheter	Device: Endocardial Ablation Procedure; Other Names: Linear Type Catheter (D-1368-01-SI); nMARQ TM Multi-channel RF generator (D-1341-07) with Software V2.4.0 or above; Linear Ablation Connection Cable (M-5948-01-I)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Onset of Primary Adverse Events	Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events	Within 7 days
Confirmation of entrance block	Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)	Intraoperative
Confirmation of bi-directional block	Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Device Effects (SADEs)	Incidence of Serious Adverse Device Effects (SADEs) during follow-up	1 Year
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia	Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure	3, 6 and 12 months post-procedure

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LME-167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No