Clinical Evaluation of Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 31
- Locations
- 3
- Primary Endpoint
- Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OPTRELL Mapping Catheter
Participants diagnosed with cardiac arrhythmias 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 OPTRELL mapping catheter.
Intervention: OPTRELL Mapping Catheter (Device)
Outcomes
Primary Outcomes
Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters
Time Frame: Up to 72 days
Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported.
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter
Time Frame: Up to 7 days of index procedure at Day 0
Number of participants with SAEs within 7 days of index procedure related to the OPTRELL 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
- Number of Responders for Physician Assessment for Signal Collection and Quality(Up to 72 days)
- Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping(Up to 72 days)
- Number of Responders for Physician Assessment for Maneuverability & Handling(Up to 72 days)
- Number of Responders for Physician Assessment for Catheters Interactions(Up to 72 days)
- Number of Participants With SAEs Within 7 Days of Index Procedure(Up to 7 days of index procedure at Day 0)
- Number of Responders for Physician Assessment for Workflow(Up to 72 days)
- Number of Responders for Physician Assessment for Ability to Characterize the Tissue(Up to 72 days)
- Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter(Up to 7 days of index procedure at Day 0)
- Number of Responders for Physician Assessment for Pacing(Up to 72 days)
- Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI(Up to 72 days)
- Number of Responders for Physician Assessment for Catheter Visualization(Up to 72 days)
- Number of Responders for Physician Assessment for Arrhythmogenicity(Up to 72 days)