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

Feasibility of the CARTOFINDER™ 4D LAT Algorithm to Identify Ablation Target in Subjects With Atrial Fibrillation (FIND CAN Trial: "CF-172")

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.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Ablation procedure

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate mapping characteristics	Explore characteristics of ablation targets identified by the CARTOFINDER 4D LAT Algorithm	Intraoperative
Evaluate acute safety of freedom from procedure-related primary adverse events	Evaluate acute safety of freedom from procedure-related primary adverse events occurring within 7 days of ablation procedure	Within 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate atrial fibrillation (AF) termination	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	Perioperative

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): May 4, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI CF-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No