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FIND CAN Trial: "CF-172" (FIND CAN)

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: NCT03033641
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
The purpose of this feasibility study is to further explore characteristics of ablation targets identified by CARTOFINDER 4D LAT Algorithm in subjects with persistent atrial fibrillation and to assess the acute outcome of CARTOFINDER Guided Ablation in terms of the termination of atrial fibrillation to either Normal Sinus Rhythm or Atrial Tachycardia.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of the CARTOFINDER™ 4D LAT Algorithm to Identify Ablation Target in Subjects With Atrial Fibrillation (FIND CAN Trial: "CF-172")
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ablation procedure Device: Ablation procedure
All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study.
Other Name: CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)




Primary Outcome Measures :
  1. Evaluate mapping characteristics [ Time Frame: Intraoperative ]
    Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm

  2. Evaluate acute safety of freedom from procedure-related primary adverse events [ Time Frame: Within 7 days ]
    Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure


Secondary Outcome Measures :
  1. Evaluate atrial fibrillation (AF) termination [ Time Frame: Perioperative ]
    Evaluate the AF termination to Normal Sinus Rhythm (NSR) or an Atrial Tachycardia (AT) after CARTOFINDER™ Guided Ablation (CFGA) of identified ablation target and after PVI



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:

Subjects must meet the following inclusion criteria:

  1. Age > 18 years.
  2. Patients who have signed the Patient Informed Consent Form (ICF)
  3. Scheduled to undergo a clinically-indicated catheter ablation procedure for treatment of persistent atrial fibrillation (defined as continuous atrial fibrillation that is sustained beyond seven consecutive days).

    3.1. Drug-refractory atrial fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)

  4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)

Exclusion Criteria:

Subject who meet any of the following exclusion criteria are not eligible for enrollment.

  1. Paroxysmal Atrial Fibrillation
  2. Continuous AF > 12 months (1 Year) (Longstanding Persistent AF) 2.1. Subjects previously diagnosed as Long Standing Persistent (LSP) but have demonstrated the ability to maintain Normal Sinus Rhythm for >30 days after cardioversion and have not been in AF greater than 1 year at the time of the procedure remain eligible for inclusion.
  3. Previous ablation procedure for AF (previous ablation for the treatment of Flutter is acceptable)
  4. Patients with a left atrial size >55 mm (echocardiography, parasternal long axis view).
  5. Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the investigator.
  6. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  7. Atrial arrhythmia patients with structural atrial disease such as a prior history of atriotomy from prior atrial surgery, presence of an atrial septal defect, and/or presence of an atrial septal closure patch.
  8. History of or current blood clotting or bleeding abnormalities, contraindication to systemic anticoagulation (i.e., heparin, warfarin, dabigatran, or a direct thrombin inhibitor), significant pulmonary disease, unstable angina, uncontrolled heart failure, acute illness or systemic infection, or any other disease or malfunction that would preclude treatment in the opinion of the investigator.
  9. Enrollment in a study evaluating another device or drug.
  10. A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  11. Patients with a prosthetic mitral valve or any mechanical valve
  12. Any cardiac surgery within the past 60 days (2 months) (includes PCI) (bypass within the past year)
  13. Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
  14. Prior ICD or pacemaker implanted
  15. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  16. Presence of a condition that precludes vascular access.
  17. Subject has a contra-indication to any of the devices used in the study per the IFU
  18. Women of child bearing potential who are pregnant, lactating, or planning to become pregnant during the course of the trial.

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): NCT03033641


Locations
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Canada, Ontario
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2P9
Sponsors and Collaborators
Biosense Webster, Inc.
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT03033641    
Other Study ID Numbers: BWI CF-172
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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