NCT07541092 The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles
| NCT ID | NCT07541092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Ventricular Arrythmia |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-12-30 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Haisam Ismail, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT07541092 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ventricular Arrythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541092 currently recruiting?
Yes, NCT07541092 is actively recruiting participants. Contact the research team at seliareddy@northwell.edu for enrollment information.
Where is the NCT07541092 trial being conducted?
This trial is being conducted at New Hyde Park, United States.
Who is sponsoring the NCT07541092 clinical trial?
NCT07541092 is sponsored by Northwell Health. The principal investigator is Haisam Ismail, MD at Northwell Health. The trial plans to enroll 20 participants.