CellFX® nsPFA™ for Atrial Fibrillation
(NANOCLAMP-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new device, the CellFX® nsPFA™ Cardiac Surgery System, to determine its safety and effectiveness in treating atrial fibrillation (an irregular heart rhythm) during heart surgery. Researchers are considering this treatment for individuals already scheduled for heart surgery, such as valve repair or coronary artery bypass. It suits those who have experienced atrial fibrillation within the past year and are planning non-emergency heart surgery. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the CellFX® nsPFA™ Cardiac Surgery System is safe for treating atrial fibrillation?
Research has shown that the CellFX® nsPFA™ Cardiac Surgery System is proving to be safe. In one study, patients using this device experienced no serious side effects, indicating no severe negative reactions from the treatment. An early death occurred in a group using a different method, but it was unrelated to the CellFX® system.
These results suggest that the CellFX® system is generally well-tolerated by patients. While this is promising, potential participants should review all information and consult their healthcare providers before deciding to join a trial.12345Why are researchers excited about this trial?
Researchers are excited about the CellFX® nsPFA™ Cardiac Surgery System because it uses a novel approach called non-thermal pulsed field ablation (nsPFA) to treat atrial fibrillation. Unlike standard treatments that often rely on heat or freezing to create lesions in the heart tissue, nsPFA uses electrical pulses to disrupt heart cells in a more precise manner. This method aims to minimize damage to surrounding healthy tissue, potentially leading to fewer side effects and a quicker recovery. This innovative approach could offer a safer and more effective alternative for patients undergoing cardiac surgery.
What evidence suggests that the CellFX® nsPFA™ Cardiac Surgery System is effective for atrial fibrillation?
Research has shown that the CellFX® nsPFA™ Cardiac Surgery System, which participants in this trial will receive, yields promising results for treating atrial fibrillation, a type of irregular heartbeat. One study found that all treated areas of damaged heart tissue were successfully blocked. Another study reported a 92.4% success rate in isolating the pulmonary veins, which helps stop irregular heartbeats. Early trials with humans successfully treated atrial fibrillation in 30 patients. Additionally, tests on animals confirmed that this treatment is safe and effective for heart tissue. These findings suggest that the CellFX nsPFA System could be a strong option for managing atrial fibrillation during surgery.14567
Who Is on the Research Team?
Matthew A. Romano, MD
Principal Investigator
University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center
Are You a Good Fit for This Trial?
This trial is for individuals with a history of atrial fibrillation within the past year, who have at least a 30% left ventricular ejection fraction and are scheduled for non-emergency open-heart surgery. They must live near the study site, be able to consent to the procedure, and complete follow-ups. Life expectancy should be at least 5 years.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a concomitant cardiac surgical procedure with nsPFA ablation and treatment of left atrial appendage
Follow-up
Participants are monitored for safety and effectiveness after treatment, including freedom from AF/AFL/AT and adverse events
Long-term Follow-up
Quality of Life (QoL) assessments using AFEQT and SF-12 at 6 and 12 months post-ablation procedure
What Are the Treatments Tested in This Trial?
Interventions
- CellFX® nsPFA™ Cardiac Surgery System
Trial Overview
The CellFX® nsPFA™ Cardiac Surgery System is being tested for safety and effectiveness in treating atrial fibrillation during cardiac surgeries like valve repairs or bypasses. The system uses nanosecond pulsed field ablation as part of the treatment process.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adult subjects who are eligible to participate will undergo a concomitant cardiac surgical procedure with nsPFA ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) and treatment of left atrial appendage.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulse Biosciences, Inc.
Lead Sponsor
Avania
Industry Sponsor
Citations
Study Details | NCT06355063 | CellFX® nsPFA™ Cardiac ...
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion ...
2.
investors.pulsebiosciences.com
investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-announces-late-breaking-data-its-nanosecondPress Release - Pulse Biosciences Inc.
All (100%) lesions were acutely successful with conduction block. · Success rate of PVI at ~3 months was 92.4% (109/118). · Total PVI ablation ...
The performance of a new nanosecond pulsed-field ...
This porcine model demonstrates safety and efficacy of a new nanosecond pulsed field ablation (nsPFA) parallel clamp in ablating cardiac tissue.
The performance of a new nanosecond pulsed-field ...
This porcine model demonstrates safety and efficacy of a new nanosecond pulsed field ablation (nsPFA) parallel clamp in ablating cardiac tissue. This technology ...
Pulse Biosciences Announces Presentation of Late- ...
Successfully treated atrial fibrillation (AF) in initial 30 patients with the nPulse™ Cardiac Surgical System. HAYWARD, Calif.
6.
investors.pulsebiosciences.com
investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-announces-fda-ide-approval-initiate-its-npulsePulse Biosciences Announces FDA IDE Approval to Initiate its ...
This single-arm, multicenter, prospective study is designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Catheter System ...
CellFX® Nanosecond Pulsed Field Ablation (nsPFA) ...
The primary objective of this RCT Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in ...
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