NCT05164107 Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
| NCT ID | NCT05164107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kardium Inc. |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2021-12-08 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2021-12-08 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
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
Contact & Investigator
Motol and Homolka University Hospital
PRINCIPAL INVESTIGATOR
V Úvalu 84/1, 150 00 Prague 5, Czech Republic
Frequently Asked Questions
Who can join the NCT05164107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05164107 currently recruiting?
Yes, NCT05164107 is actively recruiting participants. Contact the research team at Clinical.Affairs@kardium.com for enrollment information.
Where is the NCT05164107 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT05164107 clinical trial?
NCT05164107 is sponsored by Kardium Inc.. The principal investigator is Motol and Homolka University Hospital at V Úvalu 84/1, 150 00 Prague 5, Czech Republic. The trial plans to enroll 175 participants.
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