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OpenTrials
Completed

NCT Number: NCT02565069

Identification for the Treatment of Complex Arrhythmias

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Algemeen Ziekenhuis (AZ) Sint Jan Brugge, Ruddershove, Brugge, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CartoFinder™ Device with CARTO® 3 System V5 Navigation

Device

Ablation treatment

Primary outcomes

  1. Identify rate of slowing for the overall mean atrial fibrillation rate

    Time frame: Day 0 (procedure date)

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

  2. Evaluate Freedom from procedure-related primary adverse events

    Time frame: 7 days

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

Secondary outcomes

  1. Evaluate procedural results

    Time frame: Day 0 (procedure date)

    Proportion of subjects with focal impulses / Repetitive Activation Pattern (RAP)s and number of areas and locations of focal impulses / RAPs

  2. Evaluate procedural results

    Time frame: Day 0 (procedure date)

    Proportion of subjects with Normal Sinus Rhythm (NSR) after CF guided ablation

  3. Evaluate procedural results

    Time frame: Day 0 (procedure date)

    Proportion of subjects with AF organization after CF guided ablation

  4. Evaluate procedural results

    Time frame: Day 0 (procedure date)

    Proportion of subjects with acute procedural success, i.e. subjects with spontaneous return to NSR or AF organization after CF guided ablation

  5. Evaluate freedom from documented recurrence of atrial fibrillation

    Time frame: 6 and 12 months

    Evaluate freedom from documented recurrence of atrial fibrillation at 6 and 12 months post-procedure

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

Identification for the Treatment of Complex Arrhythmias (CartoFinder™ Algorithm Trial: "CF163 EU")

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 1, 2015
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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