CSE Ablation for Atrial Fibrillation
(COHERENT-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for atrial fibrillation (AF), a heart condition causing irregular and often rapid heartbeats. The study tests the Argá Medtech CSE Ablation System, a medical device, to evaluate its safety and effectiveness in treating AF by targeting the pulmonary veins around the heart. Participants should have drug-resistant AF and experience noticeable symptoms, either in short episodes or lasting over a week but less than a year. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research and potentially benefit from an innovative treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have had effectiveness failure, intolerance, or a contraindication to at least one Class I or III anti-arrhythmic drug, which might imply some changes to your medication. It's best to discuss your specific medications with the trial team.
What prior data suggests that the Argá Medtech CSE Ablation System is safe for treating atrial fibrillation?
Research has shown that the Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System is likely safe for treating atrial fibrillation, a common heart rhythm problem. Studies have noted the safety of the technique used, called pulsed field ablation (PFA).
Although specific numbers from these studies aren't provided, the overall feedback remains positive. Reports of serious side effects are absent, indicating that most people handled the treatment well. This is particularly promising given the treatment's novel method of targeting heart tissue.
In summary, current research suggests that the CSE Ablation System is safe and generally well-tolerated by patients, with no major safety issues reported so far.12345Why are researchers excited about this trial?
Researchers are excited about the Coherent Sine-Burst Electroporation (CSE) ablation system because it offers a novel approach to treating atrial fibrillation (AF) by using precise electrical pulses to achieve pulmonary vein isolation. Unlike traditional catheter ablation techniques that rely on heat or freezing, this system uses a unique electroporation method that can potentially reduce damage to surrounding tissues and improve safety and efficacy. The CSE ablation system aims to provide a more controlled and targeted treatment, which could lead to better outcomes and fewer complications for patients with both paroxysmal and persistent AF.
What evidence suggests that the Argá Medtech CSE Ablation System is effective for atrial fibrillation?
This trial will evaluate the Arga Medtech Coherent Sine-Burst Electroporation (CSE) system for treating atrial fibrillation (AF), which can be either occasional (paroxysmal) or constant (persistent). Participants with paroxysmal AF will be in one treatment arm, while those with persistent AF will be in another. Research has shown that the CSE system could be helpful, as earlier studies demonstrated over 94% success in maintaining the effectiveness of treated areas for at least 3 months. Additionally, 92.6% of these patients did not experience any AF episodes after treatment. This suggests that the CSE system might be a good option for achieving pulmonary vein isolation, a common goal in treating AF, and indicates the potential for long-lasting relief from AF symptoms.12467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Quality of Life Assessment
Change in EQ-5D-3L and AFEQT scores are assessed to measure the impact of treatment on quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arga Medtech SA
Lead Sponsor
Citations
Study Details | NCT05572047 | Coherent Sine Burst (CSE) ...
Study Overview. Brief Summary. To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.
First Enrollments in COHERENT-AF IDE Clinical Trial
The CSE system has been used to date in over 100 patients demonstrating greater than 94% lesion durability at 3 months, 92.6% freedom from ...
Sine wave electroporation in patients with atrial fibrillation
Objective. BURST-AF evaluated safety and lesion durability of a novel PFA system, Coherent Sine Burst Electroporation (CSE). Methods.
Initial Results of the BURST-AF Study
Results from the BURST-AF clinical trial of #ArgaMedtech's Coherent Sine Burst pulsed field ablation system were presented today at #HRS2025 ...
NCT06784466 | Coherent Sine Burst Electroporation (CSE ...
Study Overview. Brief Summary. To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
PO-03-069 COHERENT SINE BURST ...
Pulsed field ablation (PFA) has a promising safety profile for treatment of atrial fibrillation. PFA is currently implemented using square waves and varying ...
Coherent Sine Burst Electroporation (CSE) Ablation ...
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
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