The Comparative Advantage of the Optrell Mapping Catheter... | NCT07541092

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

NCT07541092

Sponsor

Northwell Health

Status

Recruiting

Last Update Posted

Apr 21, 2026Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Ventricular Arrythmia

Interventions

Ablation using Optrell™ mapping catheter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2024Actual

Primary Completion Date

Dec 30, 2028Estimated

Completion Date

Dec 30, 2028Estimated

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

Apr 17, 2026

First Posted Date

Apr 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2026

Last Update Posted Date

Apr 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients aged 18-75 diagnosed with ventricular arrhythmias.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Salome Elia Reddy	Contact	516-600-1459		seliareddy@northwell.edu

Overall Officials

Name	Affiliation	Role
Haisam Ismail, MD	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long Island Jewish Medical Center	Recruiting	New Hyde Park	New York	11040	United States