FIND CAN Trial: "CF-172"

NCT03033641 | Completed

• 1 other identifier: BWI CF-172
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluate atrial fibrillation (AF) termination

  Perioperative

Study Arms (1)

Ablation procedure

EXPERIMENTAL

Device: Ablation procedure

Interventions

Ablation procedure DEVICE

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.

Also known as: CARTOFINDER™ Workstation, CARTO® 3 EP Navigation System, with CARTOFINDER™ 4D LAT Algorithm installed (CARTOFINDER™ Module)

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.
• Patients who have signed the Patient Informed Consent Form (ICF)
• 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).
• 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)
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements (e.g. patients not confined by a court ruling)

You may not qualify if:

• Paroxysmal Atrial Fibrillation
• Previous ablation procedure for AF (previous ablation for the treatment of Flutter is acceptable)
• Patients with a left atrial size \>55 mm (echocardiography, parasternal long axis view).
• Inability to restore sinus rhythm for 30 seconds or longer in the opinion of the investigator.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• 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.
• 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.
• Enrollment in a study evaluating another device or drug.
• A complex arrhythmia secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Patients with a prosthetic mitral valve or any mechanical valve
• Any cardiac surgery within the past 60 days (2 months) (includes PCI) (bypass within the past year)
• Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Prior ICD or pacemaker implanted
• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
• Presence of a condition that precludes vascular access.

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: December 22, 2016
• First Posted: January 27, 2017
• Study Start: December 5, 2016
• Primary Completion: May 4, 2017
• Study Completion: August 30, 2017
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share