Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
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 30 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation using study catheter | Experimental | All patients will undergo a standard ablation protocol using the study catheter (Farapoint) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point Ablation Catheter | Device | a point ablation catheter using a pulse field energy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)) | at 3 months following ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | Safety is measured as incidence of Serious Adverse Device Effects (SADEs) | at 3 months following ablation procedure |
| Incidence of Serious Adverse Events (SAEs) | Safety is measured as incidence of Serious Adverse Events (SAEs) |
Not provided
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:
Able and willing to provide written consent and comply with all testing and follow-up requirements
Above 18 years of age
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
single-arm clinical pilot study; all patients will undergo a standard ablation protocol using the study catheter (Farapoint).
Not provided
Not provided
Not provided
Not provided
| at 3 months following ablation procedure |
| Incidence of non-serious adverse events | Safety is measured as incidence of non-serious adverse events | at 3 months following ablation procedure |
| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
Not provided
Not provided