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NCT Number: NCT07116525

A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included)
  • At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months prior to enrollment
  • Age 18 years or older
  • Signed Patient Informed Consent Form (ICF)
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion criteria

  • Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
  • Patients requiring left atrial procedures: left atrial size greater than (>) 55 millimeter (mm)
  • Left ventricular ejection fraction(LVEF) less than or equal to (<=) 25 percentage (%) for participants with ventricular arrhythmia
  • LVEF <= 40% for participants with atrial arrhythmia
  • Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
  • Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)
  • History of blood clotting or bleeding abnormalities (example hypercoagulable state)
  • Myocardial infarction within the past 2 months (60 days)
  • Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months (365 days)
  • Uncontrolled heart failure or New York heart association (NYHA) function class IV
  • Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days)
  • Patients with known untreatable allergy to contrast media
  • Active illness or active systemic infection or sepsis
  • Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
  • Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior
  • Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention [PCI])
  • Atrial septal closure within the past 6 weeks (42 days)
  • Presence of a condition that precludes vascular access
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
  • Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
  • Concurrent enrollment in an investigational study evaluating another device or drug

Treatment and study plan

Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter

Device

High-density, multi-electrode mapping catheter will be used for the procedure.

Primary outcomes

  1. Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping

    Time frame: Up to 7 days post index procedure

    A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

  2. Incidence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping

    Time frame: Up to 7 days post index procedure

    Incidences of all pre-ablation endocardial mapping requirements and any clinically indicated endocardial mapping with the investigational catheter, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.

Secondary outcomes

  1. Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality

    Time frame: Up to 7 days post index procedure

    Physician feedback on the catheter deployment, visualization, maneuverability, and signal quality acquired with the investigational catheter for mapping of the atria and ventricles, inclusive of endocardial and epicardial spaces, using a physician-completed survey, using a Likert scale of 1 to 7 (1=poor and 7=excellent) will be summarized.

  2. Incidence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion

    Time frame: Up to 7 days post index procedure

    A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.

  3. Incidence of all Other SAEs Not Related to the Investigational Catheter

    Time frame: Up to 7 days post index procedure

    Incidence with all other SAEs not related to the investigational catheter will be reported.

  4. Incidence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter

    Time frame: Up to 7 days post index procedure

    Incidence with non-serious AEs related to the investigational catheter will be reported.

  5. Incidence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion

    Time frame: Up to 7 days post index procedure

    Incidence of completion with all pre-ablation epicardial mapping requirements and any clinically indicated epicardial mapping with the investigational catheter as per physician's discretion, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter

Acronym: FEATHER

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 11, 2025
Registry last updated
Jul 6, 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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