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

NCT ID: NCT02991313

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-11-30

Brief Summary

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endocardial Ablation Procedure

ablation with Linear type catheter

Group Type: EXPERIMENTAL

Endocardial Ablation Procedure

Intervention Type: DEVICE

Interventions

Endocardial Ablation Procedure

Intervention Type: DEVICE

Other Intervention 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)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LME-167

Identifier Type: -

Identifier Source: org_study_id