NCT06747013
Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
Enrolling by Invitation
NAAges 18+InterventionalTreatmentVivek ReddyInvestigator-initiated
~60 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Point Ablation Catheter
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from PVC/VT recurrence
Measured over at 3 months following ablation procedure
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Vivek Reddy, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Exclusion
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
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.
What this trial measures
- Freedom from PVC/VT recurrenceat 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))