An interventional study of Point Ablation Catheter in Focal Ventricular Arrhythmias, Premature Ventricular Contractions and Ventricular Tachycardias, sponsored by Vivek Reddy. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Vivek Reddy · Not applicable, Interventional, and Treatment
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.
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's enrollment of 60 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Vivek Reddy is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will undergo a standard ablation protocol using the study catheter (Farapoint)
Device: Point Ablation Catheter
a point ablation catheter using a pulse field energy
Also known as: Farapoint
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))
Time frame: at 3 months following ablation procedure
Incidence of Adverse events
Safety is measured as incidence of Serious Adverse Device Effects (SADEs)
Time frame: at 3 months following ablation procedure
Incidence of Serious Adverse Events (SAEs)
Safety is measured as incidence of Serious Adverse Events (SAEs)
Time frame: at 3 months following ablation procedure
Incidence of non-serious adverse events
Safety is measured as incidence of non-serious adverse events
Time frame: at 3 months following ablation procedure
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Feb 2027, 25 months after the start.
Of 32 interventional studies with no phase under Ventricular Premature Complexes, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 25 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Dec 2026 → Feb 2027 and completion Dec 2026 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Vivek Reddy