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

NCT07541092 | Recruiting

• 1 other identifier: 24-0567
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventricular Arrythmia

Outcome Measures

Primary Outcomes (2)

• Evaluate acute success in eliminating premature ventricular contractions

  During procedure

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

  At 3 months follow post-procedure

Interventions

Ablation using Optrell™ mapping catheter PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-75 diagnosed with ventricular arrhythmias.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Study Officials

• Haisam Ismail, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salome Elia Reddy

CONTACT

516-600-1459; seliareddy@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: April 21, 2026
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)