Comparing the Optrell mapping catheter for papillary muscle ventricular arrhythmias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults undergoing routine ablation guided by the Optrell™ mapping catheter with TRUEref technology for ventricular arrhythmias originating from the papillary muscles. The catheter's narrow electrode spacing and ability to achieve simultaneous contact of multiple bipoles aim to reveal small local activation differences and to move with the papillary muscle for more accurate timing allocation. Intracardiac echocardiography may be used to help position the catheter optimally on the papillary muscle surface. The primary goal is to explore whether this mapping approach offers practical advantages in mapping speed and spatial resolution compared with typical mapping during standard clinical care.

Why it matters

Who can join: the full rules

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

Where it's running

• Long Island Jewish Medical Center
  New Hyde Park, New York, United States Recruiting

Study contacts

• Principal investigator: Haisam Ismail, MD — Northwell Health
• Study coordinator: Salome Elia Reddy
• Email: seliareddy@northwell.edu
• Phone: 516-600-1459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.