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The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles

Who can join

Ages 18 to 75 · All sexes

Inclusion Criteria:

* 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
* Patients with frequent (\>10%) or symptomatic PVCs with ECG morphology consistent with papillary muscle origin.
* Papillary muscle PVCs in setting of cardiomyopathy.
* Patients prescribed by their treating physician to undergo the procedure with the Optrell™ mapping catheter as part of routine clinical care.
* Patient demonstrates proficiency in the English language; reading, writing, and conversational

Exclusion Criteria:

* 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
* PVC from site other than papillary muscle
* Acute coronary syndrome
* Congestive heart failure in acute decompensation
* Rapid atrial fibrillation
* Requiring ventricular pacing

About the study

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.

What is being tested

• Ablation using Optrell™ mapping catheter (procedure)

Sponsor: Northwell Health · Participants: 20 · Started: Dec 30, 2024

Contact the study team

• Salome Elia Reddy · Phone: 516-600-1459

Official record on ClinicalTrials.gov — NCT07541092

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.