Using a special catheter to treat heart rhythm problems
Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
This study is testing a special catheter to see if it can safely treat heart rhythm problems like premature contractions and tachycardia in people scheduled for ablation procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06747013 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of a point ablation catheter, specifically the Farapoint device from Boston Scientific, in treating focal ventricular arrhythmias such as premature ventricular contractions and ventricular tachycardia. It is a prospective, single-center, single-arm pilot study that aims to enroll 30 subjects who are scheduled for catheter ablation procedures. Participants will undergo pre-procedural testing, the ablation procedure, and a follow-up period of three months to assess the success of the treatment based on specific effectiveness endpoints.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for catheter ablation due to symptomatic premature ventricular contractions or sustained monomorphic ventricular tachycardia.
Not a fit: Patients with contraindications to anticoagulation or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the burden of ventricular arrhythmias for patients, improving their quality of life.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in the treatment of ventricular arrhythmias using catheter ablation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Vivek Reddy, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Betsy Ellsworth, MSN
- Email: betsy.ellsworth@mountsinai.org
- Phone: 347-498-3855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.