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

Primary Purpose

Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Scar-related Atrial Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Onze-Lieve-Vrouw (OLV) Ziekenhuis
Universitair Ziekenhuis (UZ) Brussel
University Hospital Center Split
Ospedale Generale Regionale Francesco Miulli (F. Miulli)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Participants with cardiac arrhythmias/ablation history who are scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures will be using multi-electrode mapping catheter.

Outcomes

Primary Outcome Measures

Number of Participants with Pre-ablation Mapping Performed Successfully with the Globe-Shaped, High-Density Multi-electrode Mapping Catheter Without Resort to Non-study Mapping Catheter

Number of participants with pre-ablation mapping performed successfully with the globe-shaped, high-density multi-electrode mapping catheter without resort to non-study mapping catheter will be reported. Pre-ablation mapping is considered complete when all of the following are accomplished, as applicable: 1) The entire chamber and areas associated with the targeted arrhythmia(s) are completely mapped using Fast Anatomical Mapping (FAM); 2) Substrate or previous lesion line associated with the arrhythmia(s) is mapped: a) Substrate Voltage mapping recommended for re-do Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PsAF) and Ventricular Tachycardia (VT) procedures; b) Local activation mapping recommended for complex Atrial Tachycardia (AT) and VT procedures; 3) Conduction channel, gap(s) and critical isthmus are identified (as applicable); 4) Mapping density at the areas of interests (example slow conduction zones) is adequate, as assessed by the investigator.

Number of Participants with Clinically Indicated Mapping Performed Successfully with the Globe-Shaped, High-Density Multi-electrode Mapping Catheter Without Resort to Non-study Mapping Catheter

Number of participants with clinically indicated mapping performed successfully with the globe-shaped, high-density multi-electrode mapping catheter without resort to non-study mapping catheter will be reported.

Number of Participants with Serious Adverse Events (SAEs) within 7 days of Index Procedure Related to the Investigational Catheter

Number of participants with SAEs within 7 days of index procedure related to the investigational catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. A SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-participant hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.

Secondary Outcome Measures

Physician Assessment of Deployment, Maneuverability, and Signal Quality Acquired with the Globe-shaped, High-density Multi-electrode Mapping Catheter for Mapping in the Atria and Ventricles Using a Physician-completed Survey

Physician assessment of deployment, maneuverability, and signal quality acquired with the globe-shaped, high-density multi-electrode mapping catheter for mapping in the atria and ventricles using a physician-completed survey will be reported. A post-procedure survey of 11 questions, each with individual sub-questions will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.

Number of Participants with Other SAEs (Excluding Globe-shaped, High-density Multi-electrode Mapping Catheter Related SAE) within 7 days of Index Procedure

Number of Participants with other SAEs (excluding globe-shaped, high-density multi-electrode mapping catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. A SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-participant hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.

Number of Participants with Non-serious Adverse Events within 7 days of Index Procedure Related to the Globe-shaped, High-density Multi-electrode Mapping Catheter

Number of participants with non-serious adverse events within 7 days of index procedure related to the globe-shaped, high-density multi-electrode mapping catheter will be reported.

Full Information

NCT ID

NCT05373862

First Posted

May 10, 2022

Last Updated

March 13, 2023

Sponsor

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05373862

Brief Title

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

Acronym

COSMOS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

July 29, 2022 (Actual)

Primary Completion Date

February 20, 2023 (Actual)

Study Completion Date

February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia, Premature Ventricular Complex

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Number of Participants with Pre-ablation Mapping Performed Successfully with the Globe-Shaped, High-Density Multi-electrode Mapping Catheter Without Resort to Non-study Mapping Catheter

Description

Time Frame

For 1 day on the day of procedure (anytime during the study duration of 6 months)

Title

Number of Participants with Clinically Indicated Mapping Performed Successfully with the Globe-Shaped, High-Density Multi-electrode Mapping Catheter Without Resort to Non-study Mapping Catheter

Description

Time Frame

Up to 6 months

Title

Number of Participants with Serious Adverse Events (SAEs) within 7 days of Index Procedure Related to the Investigational Catheter

Description

Time Frame

Up to 7 days of index procedure

Secondary Outcome Measure Information:

Title

Description

Time Frame

Up to 6 months

Title

Number of Participants with Other SAEs (Excluding Globe-shaped, High-density Multi-electrode Mapping Catheter Related SAE) within 7 days of Index Procedure

Description

Time Frame

Up to 7 days of index procedure

Title

Number of Participants with Non-serious Adverse Events within 7 days of Index Procedure Related to the Globe-shaped, High-density Multi-electrode Mapping Catheter

Description

Number of participants with non-serious adverse events within 7 days of index procedure related to the globe-shaped, high-density multi-electrode mapping catheter will be reported.

Time Frame

Up to 7 days of index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Biosense Webster, Inc. Clinical Trial

Organizational Affiliation

Biosense Webster, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Onze-Lieve-Vrouw (OLV) Ziekenhuis

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Universitair Ziekenhuis (UZ) Brussel

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

University Hospital Center Split

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Ospedale Generale Regionale Francesco Miulli (F. Miulli)

City

Acquaviva delle fonti

ZIP/Postal Code

70021

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

IPD Sharing URL

http://yoda.yale.edu

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

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