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

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991313
• Other study ID #: LME-167
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Endocardial Ablation Procedure

Locations

Country	Name	City	State
Italy	Ospedale Generale Regionale "F. Miulli"	Sant'Eramo
Italy	Ospedale San Giovanni Battista Molinette	Torino
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	St Thomas' Hospital London	London

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Onset of Primary Adverse Events	Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events	Within 7 days
Primary	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
Primary	Confirmation of bi-directional block	Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions	Intraoperative
Secondary	Incidence of Serious Adverse Device Effects (SADEs)	Incidence of Serious Adverse Device Effects (SADEs) during follow-up	1 Year
Secondary	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