Ventricular Arrythmia
Conditions
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.
Interventions
PROCEDUREAblation 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.
Sponsors
Northwell Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
CONTACTSalome Elia Reddy
PRINCIPAL_INVESTIGATORHaisam Ismail, MD
Northwell Health
Outcome results
None listed