Clinical trial NCT04983797: A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
Official title: Clinical Evaluation of Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar-related Atrial Tachycardia
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Tachycardia, Ventricular
Ventricular Premature Complexes
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, 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, 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 Participant 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 Ventricular Tachycardia (VT) participants
* LVEF \<= 40% for participants with atrial arrhythmia
* Documented intracardiac thrombus as detected on imaging
* 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)
* Implanted with a prosthetic valve
* 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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter
timeFrame: Up to 7 days of index procedure at Day 0
measure: Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters
timeFrame: Up to 72 days
Secondary outcomes:
measure: Number of Participants With SAEs Within 7 Days of Index Procedure
timeFrame: Up to 7 days of index procedure at Day 0
measure: Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter
timeFrame: Up to 7 days of index procedure at Day 0
measure: Number of Responders for Physician Assessment for Maneuverability & Handling
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Signal Collection and Quality
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Pacing
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Workflow
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Catheter Visualization
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Catheters Interactions
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Arrhythmogenicity
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
timeFrame: Up to 72 days
measure: Number of Responders for Physician Assessment for Ability to Characterize the Tissue
timeFrame: Up to 72 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: UZ Antwerpen
city: Hasselt
country: Belgium
facility: Virga Jessa Ziekenhuis
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
Study officials:
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