Identification for the Treatment of Complex Arrhythmias

NCT02565069 | Completed Phase 4

• 1 other identifier: FIND-EU - CF163
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.

Conditions

Arrhythmias

Outcome Measures

Primary Outcomes (2)

• Identify rate of slowing for the overall mean atrial fibrillation rate

  Identify rate of slowing for the overall mean atrial fibrillation rate that can be achieved by using CARTOFINDER™ 4D LAT Algorithm

  Day 0 (procedure date)

• Evaluate Freedom from procedure-related primary adverse events

  Evaluate Freedom from procedure-related primary adverse events at 7 days post-procedure

  7 days

Secondary Outcomes (5)

• Evaluate procedural results

  Day 0 (procedure date)

• Evaluate procedural results

  Day 0 (procedure date)

• Evaluate procedural results

  Day 0 (procedure date)

• Evaluate procedural results

  Day 0 (procedure date)

• Evaluate freedom from documented recurrence of atrial fibrillation

  6 and 12 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Use of CartoFinder™ device with CARTO® 3 System V5 Navigation to treat complex arrhythmias

Device: CartoFinder™ Device with CARTO® 3 System V5 Navigation

Interventions

CartoFinder™ Device with CARTO® 3 System V5 Navigation DEVICE

Ablation treatment

Treatment group

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.
• 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-resistant Atrial Fibrillation. (failed 1 or more class I or III antiarrhythmic drugs) and demonstrating Persistent AF (requiring drugs or electrical shock to terminate)
• Persistent AF despite prior conventional ablation.
• Previous procedure permitted but limited to single Pulmonary Vein Isolation (PVI).
• In AF at the time of the Pre-CartoFinder Map (spontaneous or induced)
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

You may not qualify if:

• Paroxysmal Atrial Fibrillation
• Continuous AF \> 12 months (1-Year) (Longstanding Persistent AF)
• Cardioversion refractory (The inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. If a patient does not have documented evidence of being successfully cardioverted (Normal Sinus Rhythm (NSR) \> 30 secs), the patient must be cardioverted prior to the ablation procedure. Failure to cardiovert based on the above criteria is considered a screen failure.
• A complex arrhythmia secondary to a reversible or non-cardiac cause. For example: a complex arrhythmia secondary to electrolyte imbalance or thyroid disease.
• Left atrial size \>55 mm (echocardiography, parasternal long axis view).
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• 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, cardiac surgeries, 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 an experimental study evaluating another device or drug under investigation.
• Prosthetic valve
• Presence of intramural thrombus, tumor or other abnormality / condition that precludes vascular access, catheter introduction or manipulation.
• Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial.
• Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions For Use.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: July 1, 2015
• Primary Completion: January 24, 2017
• Study Completion: January 24, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01