About this trial
We believe that the design of the Optrell™ mapping catheter with TRUEref technology allows for faster and more accurate mapping not only due to narrow electrode spacing but also due to the ability to achieve simultaneous contact of multiple bipoles with the surface of the papillary muscle. Simultaneous mapping of multiple sites on the same surface will allow operators to appreciate small activation differences that typically exist between neighboring sites during papillary muscle ventricular arrhythmias. In addition, the position of the Optrell™ mapping catheter on the papillary muscle allows the mapping catheter to move with the papillary muscle rendering a more accurate allocation of the activation time to the surface of the papillary muscle. We also believe that optimal positioning between the Optrell™ mapping catheter and papillary muscles can be assisted by using intracardiac echocardiography. The goal of the study is to explore the utility and superiority of a specific mapping catheter, the Optrell™ mapping catheter with TRUEref.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
Patient is not cognitively impaired, pregnant, prisoner, employed by Northwell, uninsured, or a student
Age 18-75 years old with the ability to consent for the procedure
Patient is consented within the enrollment window of the therapy received, as applicable
Disqualifiers
Patient who is, or is expected to be, inaccessible for follow-up
Participation is excluded by local law
Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the study results
Unable to consent
Trial population
Patients aged 18-75 diagnosed with ventricular arrhythmias.
Trial design
Cohort
Prospective
Treatments tested in this trial
Ablation using Optrell™ mapping catheter
Procedure/SurgeryThe Optrell™ mapping catheter with TRUEref technology is device that is used as an option during ablation of premature ventricular contractions originating from the papillary muscles.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate acute success in eliminating premature ventricular contractions
Evaluate success at 3 months follow up in eliminating premature ventricular contractions
Sponsors and contacts
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