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Optrell Mapping Catheter Papillary Muscle Ventricular Arrhythmia NCT07541092

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Summary

NIH ClinicalTrials.gov posted an observational study (NCT07541092) evaluating the Optrell™ mapping catheter with TRUEref technology for mapping ventricular arrhythmias originating from the papillary muscles. The study will assess the catheter's ability to achieve simultaneous multi-bipole contact and use intracardiac echocardiography for optimal positioning. No compliance obligations or regulatory deadlines are associated with this study registration.

“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.”

NIH , verbatim from source
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What changed

A new observational clinical study has been registered on ClinicalTrials.gov (NCT07541092) by NIH. The study evaluates the Optrell™ mapping catheter with TRUEref technology for ventricular arrhythmias originating from the papillary muscles, examining whether its narrow electrode spacing and simultaneous multi-bipole contact capability improve mapping accuracy compared to standard approaches.

For clinical investigators and healthcare providers, this registration signals an active evaluation of a specific cardiac mapping technology in a specialized arrhythmia indication. Trial sponsors and medical device manufacturers with competing or complementary mapping catheter products should monitor study outcomes for competitive intelligence purposes. No regulatory action, compliance obligation, or enforcement implication arises from this study registration.

Archived snapshot

Apr 21, 2026

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

Observational NCT07541092 Kind: OBSERVATIONAL Apr 21, 2026

Abstract

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

Interventions: Ablation using Optrell™ mapping catheter

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical trial registration Cardiac mapping catheter study Ventricular arrhythmia research
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Healthcare Pharmaceuticals

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