Trials / Recruiting
RecruitingNCT06355063
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Pulse Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CellFX® nsPFA™ Cardiac Surgery System | 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. |
Timeline
- Start date
- 2024-07-31
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2024-04-09
- Last updated
- 2026-01-12
Locations
6 sites across 3 countries: Austria, Netherlands, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06355063. Inclusion in this directory is not an endorsement.