Phase
Condition
Circulation Disorders
Heart Disease
Heart Defect
Treatment
Point Ablation Catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 forcatheter 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 andfollow-up requirements
Above 18 years of age
Exclusion
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 12months.
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 ofprovocative 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 thyroiddisease or any reversible non-cardiac cause.
Study Design
Study Description
Connect with a study center
Icahn School of Medicine at Mount Sinai
NYC, New York 10029
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available

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