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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06355063 | Other Identifier | ClinicalTrials.gov |
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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CellFX nsPFA Treatment Arm | Experimental | Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box using the CellFX® nsPFA™ Cardiac Surgery System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellFX® nsPFA™ Cardiac Surgery System | Device | Adult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, ascending aortic aneurysms, or coronary artery bypass procedures with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute major adverse events (MAEs) | Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding. | Within 30 days post-ablation procedure |
| Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box | The ablation procedure includes pulmonary vein isolation and a series of ablation lines to create a "box lesion" on the posterior left atrial free wall. At the conclusion of both the primary and concomitant procedures, exit and/or entrance block will be performed to confirm complete isolation of the pulmonary veins and the left atrial posterior wall. | Within 24 hours post-ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with one or more SAEs | Long-term safety endpoint for the incidence of treatment-emergent adverse events [Safety and Tolerability] for subjects having one or more SAEs at each follow-up interval. | Up to 12-months post-procedure |
| Number of Participants with Long-Term Technical Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William A. Knape | Contact | +1 (919) 757-2033 | bknape@pulsebiosciences.com | |
| Aleksandra Kurek | Contact | +44 745 6655949 | aleksandra.kurek@pulsebiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Rich Nuccitelli, PhD | Pulse Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | Austria |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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This study is a prospective, multicenter, single arm, non-randomized, feasibility study.
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Long-term Technical Success of the Pulse Biosciences CellFX® nsPFA™ Cardiac Surgery System is defined as participants having confirmation of electrical isolation of the bilateral pulmonary veins and left atrial box by cardiac electroanatomical mapping 2-6 months post-ablation procedure. |
| 60-120 days following the index procedure |
| Academic Medical Center | Active, not recruiting | Amsterdam | Netherlands |
| Catharina Hospital | Recruiting | Eindhoven | Netherlands |
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| Maastricht University Medical Center+ (MUMC+) | Active, not recruiting | Maastricht | Netherlands |
| St. Antonius Hospital | Recruiting | Nieuwegein | Netherlands |
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| State Medical Institute of the Ministry of Interior Affairs and Administration | Recruiting | Warsaw | Poland |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |