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

NCT02991313 | Completed

• 1 other identifier: LME-167
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Incidence of Serious Adverse Device Effects (SADEs)

  1 Year

• Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia

  3, 6 and 12 months post-procedure

Study Arms (1)

Endocardial Ablation Procedure

EXPERIMENTAL

ablation with Linear type catheter

Device: Endocardial Ablation Procedure

Interventions

Endocardial Ablation Procedure DEVICE

Also known as: 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)

Endocardial Ablation Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous surgical or catheter ablation for atrial fibrillation
• Current condition of continuous AF \> 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
• Any carotid stenting or endarterectomy
• Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
• LA size \> 55 mm
• LVEF \<40%
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• 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
• Uncontrolled heart failure or NYHA function class III and 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/ percutaneous 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 12 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 13, 2016
• Study Start: October 1, 2016
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01