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RecruitingNCT07541092Updated Apr 21, 2026

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

An observational study in Ventricular Arrythmia, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Northwell Health · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ventricular Arrythmia
03

In context

Lead sponsor

Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.

Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged 18-75 diagnosed with ventricular arrhythmias.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • ProcedureAblation using Optrell™ mapping catheter

    The 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.

06

What researchers measure

Primary outcomes

  1. Evaluate acute success in eliminating premature ventricular contractions

    Time frame: During procedure

  2. Evaluate success at 3 months follow up in eliminating premature ventricular contractions

    Time frame: At 3 months follow post-procedure

07

Study locations

1 of 1 sites recruiting
  • Long Island Jewish Medical Center
    New Hyde Park, New York 11040, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07541092
Lead sponsor
Northwell Health
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
Dec 30, 2024
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Apr 21, 2026

Study contacts

Salome Elia Reddy
Contact
seliareddy@northwell.edu
516-600-1459
Haisam Ismail, MD
principal investigator · Northwell Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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