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OpenTrials
Completed

NCT Number: NCT05373862

A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.

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Key information

Conditions

Scar-related Atrial Tachycardia Arrhythmias, Cardiac Atrial Fibrillation Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Paroxysmal Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Atrial Fibrillation Premature Ventricular Complex Tachycardia Tachycardia, Ventricular Ventricular Premature Complexes Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze-Lieve-Vrouw (OLV) Ziekenhuis, Aalst, Belgium

Loading trial locations.

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 (participants 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 of enrollment
  • Signed participants Informed Consent Form (ICF)
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion criteria

  • Diagnosed with an arrhythmia requiring epicardial mapping
  • Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
  • Atrial arrhythmias: participants with a left atrial size greater than (>) 55 millimeters (mm)
  • Left Ventricular Ejection Fraction (LVEF) less than or equal to (<=) 25 percent (%) 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 within the past 6 weeks (42 days)
  • Participants 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)
  • 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

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

Device

Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex).

Primary outcomes

  1. Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)

    Time frame: Up to 7 days of index procedure on Day 1

    Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.

  2. Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter

    Time frame: Up to 7 days of index procedure on Day 1

    Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Secondary outcomes

  1. Number of Responders for Physician Assessment for Maneuverability and Handling

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for maneuverability & handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability and handling.

  2. Number of Responders for Physician Assessment for Signal Collection and Quality

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality.

  3. Number of Responders for Physician Assessment for Pacing

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for pacing (high output stimulation pacing and local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.

  4. Number of Responders for Physician Assessment for Catheter Design

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design.

  5. Number of Responders for Physician Assessment for Workflow

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.

  6. Number of Responders for Physician Assessment for Catheter Visualization

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.

  7. Number of Responders for Physician Assessment for Catheters Interactions

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.

  8. Number of Responders for Physician Assessment for Arrhythmogenicity

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.

  9. Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.

  10. Number of Responders for Physician Assessment for Ability to Characterize the Tissue

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.

  11. Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly

    Time frame: Up to 29 weeks

    Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to identify arrhythmia circuit or source correctly.

  12. Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure

    Time frame: Up to 7 days of index procedure on Day 1

    Number of participants with SAEs excluding investigational catheter related within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  13. Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter

    Time frame: Up to 7 days of index procedure on Day 1

    Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

Acronym: COSMOS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2022
Registry last updated
Mar 3, 2025

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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