The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ablation using Optrell™ mapping catheter.
- Who it may be relevant to
- Registry conditions: Ventricular Arrythmia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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 measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Long Island Jewish Medical Center — New Hyde Park
Identifiers
NCT: NCT07541092 · 24-0567