Focal Ventricular ArrhythmiasFOCUS PFANCT06747013
Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
A study testing Point Ablation Catheter in people with Focal Ventricular Arrhythmias and Premature Ventricular Contractions, run by Vivek Reddy at 1 site in United States.
Trial summary
The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias
- What is being tested?
- Point Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet ALL of the following inclusion criteria to be eligible for participation in this clinical investigation:
- Patient is planned for a catheter ablation procedure to ablate either:
- Premature ventricular contractions (PVCs) and a class I or IIa indication for catheter ablation of PVCS according to the 2019 HRS/EHRA/APHRS/LAHRS guidelines
- Symptomatic Sustained Monomorphic Ventricular Tachycardia
- Able and willing to provide written consent and comply with all testing and follow-up requirements
- Above 18 years of age
Who cannot join
- Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)
- Contraindication to anticoagulation
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
- NYHA Class IV heart failure
- Severe, untreated coronary artery disease which would preclude infusion of provocative agents
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- Severe aortic stenosis (AVA < 1.0cm, or PG > 64mmHg)
- Severe mitral regurgitation.
- Allergy to contrast which is unable to be adequately pre-medicated.
- Acute non-cardiovascular illness or systemic infection
- Thrombocytopenia (platelet count < 50,000/mm3) or coagulopathy unless corrected
- Cardiogenic shock unrelated to ventricular arrhythmias
- Pregnancy or anticipated pregnancy during study follow-up
- PVCs or VT, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.
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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.
Read the detailed description
Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.
Sample Size - A total of 60 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.
Study Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.
Study Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.
Participant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.
Primary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.
- Conditions
- Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias
- Being tested
- Point Ablation Catheter
- Keywords
- Ventricular Arrhythmias, PVCs, Premature Ventricular Contractions, VT, Ventricular Tachycardias, Symptomatic Sustained Monomorphic Ventricular Tachycardia
- Medical subject headings
- Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point Ablation CatheterDevice
Also called Farapoint
a point ablation catheter using a pulse field energy
| Study group | Role | What they receive |
|---|---|---|
| Ablation using study catheter | Experimental | All patients will undergo a standard ablation protocol using the study catheter (Farapoint) Receives: Device: Point Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from PVC/VT recurrence
Freedom from PVC/VT recurrence defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.
(Sustained Focal Tachycardia is defined as that persisting for > 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope))
Measured: at 3 months following ablation procedure
Secondary outcomes (3)
Incidence of Adverse events
Safety is measured as incidence of Serious Adverse Device Effects (SADEs)
Measured: at 3 months following ablation procedure
Incidence of Serious Adverse Events (SAEs)
Safety is measured as incidence of Serious Adverse Events (SAEs)
Measured: at 3 months following ablation procedure
Incidence of non-serious adverse events
Safety is measured as incidence of non-serious adverse events
Measured: at 3 months following ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start7 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Ventricular ArrhythmiasStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm clinical pilot study; all patients will undergo a standard ablation protocol using the study catheter (Farapoint).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747013
- Sponsor's protocol ID
- STUDY-24-00971
- Acronym
- FOCUS PFA
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
- ClinicalTrials.gov ID
- NCT06747013
- Acronym / sponsor ID
- FOCUS PFA / STUDY-24-00971
- Conditions
- Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias
- Keywords
- Ventricular Arrhythmias, PVCs, Premature Ventricular Contractions, VT, Ventricular Tachycardias, Symptomatic Sustained Monomorphic Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 2024 (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.
The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.
Detailed description
Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.
Sample Size - A total of 60 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.
Study Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.
Study Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.
Participant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.
Primary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm clinical pilot study; all patients will undergo a standard ablation protocol using the study catheter (Farapoint).
| Arm | Type | Receives |
|---|---|---|
| Ablation using study catheter | Experimental | Device: Point Ablation CatheterAll patients will undergo a standard ablation protocol using the study catheter (Farapoint) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet ALL of the following inclusion criteria to be eligible for participation in this clinical investigation:
- Patient is planned for a catheter ablation procedure to ablate either:
- Able and willing to provide written consent and comply with all testing and follow-up requirements
- Above 18 years of age
Key exclusion criteria (14 listed)
- Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)
- Contraindication to anticoagulation
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
- NYHA Class IV heart failure
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 |
|---|---|---|
| Point Ablation CatheterAlso: Farapointa point ablation catheter using a pulse field energy | Device | Ablation using study catheter |
Primary outcome
Freedom from PVC/VT recurrence
Time frame: at 3 months following ablation procedure
Freedom from PVC/VT recurrence defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups. (Sustained Focal Tachycardia is defined as that persisting for > 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope))
3 secondary outcomes
Incidence of Adverse events
Time frame: at 3 months following ablation procedure
Incidence of Serious Adverse Events (SAEs)
Time frame: at 3 months following ablation procedure
Incidence of non-serious adverse events
Time frame: at 3 months following ablation 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 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Focal Ventricular Arrhythmias
RecruitingObservational study
WHEN DO WE HAVE to PERFORM CARDIAC MAGNETIC RESONANCE in PATIENTS REFERRED for PREMATURE VENTRICULAR COMPLEXES by THEIR CARDIOLOGISTS
Premature Ventricular Complexes, Ventricular Arythmias
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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point Ablation Catheter in people with Focal Ventricular Arrhythmias and Premature Ventricular Contractions, run by Vivek Reddy 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 6 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 30 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from PVC/VT recurrence (time frame: at 3 months following ablation procedure). 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 30 Jul 2026.