Clinical trial NCT02991313: Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Early Onset of Primary Adverse Events
timeFrame: Within 7 days
measure: Confirmation of entrance block
timeFrame: Intraoperative
measure: Confirmation of bi-directional block
timeFrame: Intraoperative
Secondary outcomes:
measure: Incidence of Serious Adverse Device Effects (SADEs)
timeFrame: 1 Year
measure: Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
timeFrame: 3, 6 and 12 months post-procedure
Other outcomes:
Locations:
Study officials:
References: