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

Recruiting now

Conditions studied: Ventricular Arrythmia

In brief

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.

Key facts

Study ID

NCT07541092

Run by

Northwell Health

People needed

20

Starts

2024-12-30

Expected to finish

2028-12-30

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Long Island Jewish Medical Center — New Hyde Park, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.