Recruiting

Optrell™ Mapping Catheter

Sponsor:

Northwell Health

Code:

NCT07541092

Conditions

Ventricular Arrythmia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ablation using Optrell™ mapping catheter

Study Details

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

Study ID

NCT07541092

Start date

Dec 30, 2024

Status verified date

Apr, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ablation 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.

Primary outcome measure

  • Evaluate acute success in eliminating premature ventricular contractions [ Time Frame: During procedure ]
  • Evaluate success at 3 months follow up in eliminating premature ventricular contractions [ Time Frame: At 3 months follow post-procedure ]

Central Contacts and Locations

Central contacts

Salome Elia Reddy

516-600-1459seliareddy@northwell.edu

Locations

Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Salome Elia Reddy

516-600-1459seliareddy@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-04-21.