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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Long Island Jewish Medical Center
RECRUITING
New Hyde Park
Contact Information
Primary
Salome Elia Reddy
seliareddy@northwell.edu
516-600-1459
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov