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NCT Number: NCT07541092

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location status: Recruiting

Location contact

Salome Elia Reddy

CONTACT

[email protected]

516-600-1459

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Salome Elia Reddy

CONTACT

[email protected]

516-600-1459

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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