Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endocardial Ablation Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Active illness or active systemic infection or sepsis
- Unstable angina
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation (eg, heparin or warfarin)
- Life expectancy less than 12 months
- Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
- Presence of a condition that precludes vascular access
- Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
- Currently enrolled in another device, biologics, or drug study
- Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
Sites / Locations
- Ospedale Generale Regionale "F. Miulli"
- Ospedale San Giovanni Battista Molinette
- Glenfield Hospital
- St Thomas' Hospital London
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endocardial Ablation Procedure
Arm Description
ablation with Linear type catheter
Outcomes
Primary Outcome Measures
Early Onset of Primary Adverse Events
Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
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)
Confirmation of bi-directional block
Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
Secondary Outcome Measures
Incidence of Serious Adverse Device Effects (SADEs)
Incidence of Serious Adverse Device Effects (SADEs) during follow-up
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
Full Information
NCT ID
NCT02991313
First Posted
November 28, 2016
Last Updated
April 29, 2019
Sponsor
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02991313
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endocardial Ablation Procedure
Arm Type
Experimental
Arm Description
ablation with Linear type catheter
Intervention Type
Device
Intervention Name(s)
Endocardial Ablation Procedure
Other Intervention Name(s)
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)
Primary Outcome Measure Information:
Title
Early Onset of Primary Adverse Events
Description
Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
Time Frame
Within 7 days
Title
Confirmation of entrance block
Description
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)
Time Frame
Intraoperative
Title
Confirmation of bi-directional block
Description
Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Incidence of Serious Adverse Device Effects (SADEs)
Description
Incidence of Serious Adverse Device Effects (SADEs) during follow-up
Time Frame
1 Year
Title
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
Description
Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure
Time Frame
3, 6 and 12 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Active illness or active systemic infection or sepsis
Unstable angina
History of blood clotting or bleeding abnormalities
Contraindication to anticoagulation (eg, heparin or warfarin)
Life expectancy less than 12 months
Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
Presence of a condition that precludes vascular access
Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
Currently enrolled in another device, biologics, or drug study
Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
Facility Information:
Facility Name
Ospedale Generale Regionale "F. Miulli"
City
Sant'Eramo
Country
Italy
Facility Name
Ospedale San Giovanni Battista Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
St Thomas' Hospital London
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)
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