Using a new balloon technique to treat atrial fibrillation
Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
This study is testing a new balloon technique to see if it can safely and effectively treat people with a type of irregular heartbeat called atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | CardioFocus Industry-sponsored |
| Locations | 1 site (Prague, Czech Republic) |
| Trial ID | NCT06828939 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation in patients with symptomatic paroxysmal atrial fibrillation. It is a prospective, single-arm First-in-Human study that includes patients who are undergoing their first pulmonary vein isolation procedure. Participants will be monitored for one year following the initial ablation to assess outcomes and safety. The study aims to provide insights into a novel ablation technique that may improve treatment for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with recurrent symptomatic paroxysmal atrial fibrillation who have not previously undergone catheter ablation.
Not a fit: Patients who are in overall good health and do not meet the criteria for atrial fibrillation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more effective treatment option for patients with atrial fibrillation.
How similar studies have performed: While this approach is novel, similar studies have shown promise in the use of pulsed field ablation techniques for treating atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recurrent symptomatic PAF with at least one documented episode * Failure or intolerance of at least one AAD * Age 18-75 years * Patient is indicated for an ablation procedure according to society guidelines or study site practice * Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study Exclusion Criteria: * overall good health as established by multiple criteria
Where this trial is running
Prague, Czech Republic
- Na Homolce Hospital — Prague, Czech Republic, Czechia (Recruiting)
Study contacts
- Study coordinator: Vikramaditya Mediratta, MS
- Email: vmediratta@cardiofocus.com
- Phone: 714-717-2376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.