Ventricular ArrythmiaNCT07541092
The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles
An observational study of Ventricular Arrythmia, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventricular Arrythmia
- What is being tested?
- Ablation using Optrell™ mapping catheter
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2024to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-75 diagnosed with ventricular arrhythmias.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Congestive heart failure in acute decompensation
- Rapid atrial fibrillation
- Requiring ventricular pacing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Salome Elia Reddy, 516-600-1459, seliareddy@northwell.edu
About this study
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
- Being tested
- Ablation using Optrell™ mapping catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation using Optrell™ mapping catheterProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate acute success in eliminating premature ventricular contractions
Measured: During procedure
Evaluate success at 3 months follow up in eliminating premature ventricular contractions
Measured: At 3 months follow post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Dec 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haisam Ismail, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541092
- Sponsor's protocol ID
- 24-0567
- Status last verified
- Apr 2026
- First submitted
- 14 May 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Advantage of the Optrell Mapping Catheter in Ventricular Arrhythmias From the Papillary Muscles
- ClinicalTrials.gov ID
- NCT07541092
- Acronym / sponsor ID
- 24-0567
- Conditions
- Ventricular Arrythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 diagnosed with ventricular arrhythmias.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation using Optrell™ mapping catheterThe 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. | Procedure or surgery | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Related trials for Ventricular Arrythmia
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EDEN Intracardiac Electrogram Recording and Classifying System
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Assessment of Combined CCM and ICD Device in HFrEF
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Physical Impairments in Premature Ventricular Complex
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haisam Ismail, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrythmia, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salome Elia Reddy (516-600-1459, seliareddy@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate acute success in eliminating premature ventricular contractions (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.