Comparing the Optrell mapping catheter for papillary muscle ventricular arrhythmias
The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles
This test sees if the Optrell mapping catheter helps doctors map and treat papillary muscle ventricular arrhythmias faster and more accurately in adults having ablation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New Hyde Park, New York) |
| Trial ID | NCT07541092 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with frequent (>10%) or symptomatic PVCs whose ECGs suggest papillary muscle origin and who have been prescribed the Optrell mapping catheter as part of routine care.
Not a fit: Patients whose ventricular arrhythmias do not originate from the papillary muscles, or who are ineligible for the procedure or unable to complete follow-up (including those who are pregnant, cognitively impaired, prisoners, or outside the specified age range), are unlikely to benefit from this mapping approach.
Why it matters
Potential benefit: If successful, this approach could enable faster, more precise mapping of papillary muscle arrhythmias, potentially improving ablation success and reducing arrhythmia recurrence.
How similar studies have performed: High-density and multi-electrode mapping approaches have previously improved mapping resolution in ventricular arrhythmias, but specific data demonstrating superiority of the Optrell catheter for papillary muscle sources remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Hyde Park, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.