N/A
Completed N=31
A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
Scar-related Atrial Tachycardia · Paroxysmal Atrial Fibrillation · Persistent Atrial Fibrillation · Tachycardia, Ventricular
Source: ClinicalTrials.gov NCT04983797 ↗
Enrolled (actual)
31
Serious AEs
9.7%
Results posted
Jan 2023
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter |
— | — |
| PRIMARY Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters |
31 | — |
| SECONDARY Number of Participants With SAEs Within 7 Days of Index Procedure |
3 | — |
| SECONDARY Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter |
— | — |
| SECONDARY Number of Responders for Physician Assessment for Maneuverability & Handling |
0; 0; 0; 0; 0; 6 | — |
| SECONDARY Number of Responders for Physician Assessment for Signal Collection and Quality |
0; 0; 0; 0; 1; 4 | — |
| SECONDARY Number of Responders for Physician Assessment for Pacing |
0; 0; 1; 1; 2; 2 | — |
| SECONDARY Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping |
0; 1; 0; 2; 2; 18 | — |
| SECONDARY Number of Responders for Physician Assessment for Workflow |
0; 0; 0; 10; 6; 10 | — |
| SECONDARY Number of Responders for Physician Assessment for Catheter Visualization |
0; 0; 0; 0; 7; 9 | — |
| SECONDARY Number of Responders for Physician Assessment for Catheters Interactions |
0; 0; 0; 0; 4; 12 | — |
| SECONDARY Number of Responders for Physician Assessment for Arrhythmogenicity |
0; 0; 0; 2; 5; 10 | — |
| SECONDARY Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI |
0; 0; 0; 3; 2; 7 | — |
| SECONDARY Number of Responders for Physician Assessment for Ability to Characterize the Tissue |
0; 0; 0; 0; 0; 16 | — |
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
Data sourced from ClinicalTrials.gov (NCT04983797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.