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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991313
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

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.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Endocardial Ablation Procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endocardial Ablation Procedure
ablation with Linear type catheter
Device: Endocardial Ablation Procedure
Other 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)




Primary Outcome Measures :
  1. Early Onset of Primary Adverse Events [ Time Frame: Within 7 days ]
    Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events

  2. Confirmation of entrance block [ Time Frame: Intraoperative ]
    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)

  3. Confirmation of bi-directional block [ Time Frame: Intraoperative ]
    Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions


Secondary Outcome Measures :
  1. Incidence of Serious Adverse Device Effects (SADEs) [ Time Frame: 1 Year ]
    Incidence of Serious Adverse Device Effects (SADEs) during follow-up

  2. Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia [ Time Frame: 3, 6 and 12 months post-procedure ]
    Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991313


Locations
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Italy
Ospedale Generale Regionale "F. Miulli"
Sant'Eramo, Italy
Ospedale San Giovanni Battista Molinette
Torino, Italy, 10126
United Kingdom
Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
St Thomas' Hospital London
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Biosense Webster, Inc.
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT02991313    
Other Study ID Numbers: LME-167
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes