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This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulsed field ablation | Device | Pulsed field ablation using a ultra-compliant endoscopic PFA balloon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint - Acute Procedure Success | Pulmonary vein isolation at the end of the index procedure | During procedure |
| Primary Safety Endpoint - Rate of Primary Serious Adverse Events | The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified:
| 7 days (unless otherwise specified) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness Endpoint - Chronic Durability | Percentage of treated PVs with documented PVI at the remapping procedure | 90 days |
| Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikramaditya Mediratta, MS | Contact | 714-717-2376 | vmediratta@cardiofocus.com | |
| Lisa Hausmann, MPH | Contact | 508-658-7253 | lhausmann@cardiofocus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Homolce Hospital | Recruiting | Prague | Czech Republic | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42024567 | Derived | Reddy VY, Petru J, Funasako M, Koruth JS, Neuzil P. Visually-Guided Pulsed Field Ablation for Durable Pulmonary Vein Isolation: Chronic Remapping & One-Year Outcomes in the First-in-Human VISION AF Study. JACC Clin Electrophysiol. 2026 Apr 23:S2405-500X(26)00364-6. doi: 10.1016/j.jacep.2026.04.009. Online ahead of print. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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OptiShot PFA Balloon System
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Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of > 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor
| 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |