Using a new device to map and treat atrial fibrillation

PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

This study is testing a new device to see if it can safely and effectively help people with atrial fibrillation feel better through a special treatment procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kardium Inc. (Industry-sponsored)
• Locations: 1 site (Prague)
• Trial ID: NCT05164107 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Globe Mapping and Pulsed Field Ablation System for patients with atrial fibrillation (AF). Participants will undergo a catheter ablation procedure using this innovative technology, which aims to improve treatment outcomes for AF. The study will collect clinical data to assess how well the device performs in a real-world setting. It targets individuals who have a documented history of AF and are between the ages of 18 and 75.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a documented history of atrial fibrillation who are scheduled for an AF catheter ablation procedure.

Not a fit: Patients with contraindications to open heart surgery, active systemic infections, or significant heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment options for patients suffering from atrial fibrillation.

How similar studies have performed: Other studies have shown promise with similar ablation techniques, but the specific use of the Globe Mapping and Pulsed Field Ablation System is relatively novel.

Eligibility criteria

Key Inclusion Criteria:

1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF.

   1. Diagnosis must be confirmed within 12 months before enrollment.
   2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
2. Subjects between 18 and 75 years of age, inclusive

Key Exclusion Criteria:

1. Patients who have contraindications to open heart surgery
2. Patients from an Intensive Care Unit
3. Patients with active systemic infection (sepsis)
4. Patients who have had previous ablation in the left or right atrium
5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
8. Patients with New York Heart Association Class III or IV heart failure
9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
10. Bleeding disorder history
11. Patients with a known sensitivity to anesthesia or neuromuscular block agent
12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
13. Myocardial infarction within the last three months
14. Atrioventricular (AV) block II° or III°
15. Left ventricular ejection fraction (LVEF) of less than 35%
16. Unstable angina

Where this trial is running

Prague

• Motol and Homolka University Hospital — Prague, Czechia (Recruiting)

Study contacts

• Principal investigator: Motol and Homolka University Hospital — V Úvalu 84/1, 150 00 Prague 5, Czech Republic
• Study coordinator: Clinical Affairs

Conditions Atrial Fibrillation; Globe Mapping and Ablation System; Pulsed Field Ablation