Atrial Fibrillation (Paroxysmal)
Conditions
Keywords
ablation, pulsed field ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEpulsed field ablation
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Sponsors
CardioFocus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
OptiShot PFA Balloon System
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint - Acute Procedure Success | During procedure | Pulmonary vein isolation at the end of the index procedure |
| Primary Safety Endpoint - Rate of Primary Serious Adverse Events | 7 days (unless otherwise specified) | The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * AE fistula (assessed at \>=60 days) * Cardiac perforation, tamponade, or pericardial effusion * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * MI * Pericarditis * PNI resulting in persistent diaphragmatic paralysis (assessed at \<=60 days) * PV stenosis (assessed at \<=60 days) * Stroke/CVA * Thromboembolism * TIA * Vagal nerve injury/gastroparesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint - Chronic Durability | 90 days | Percentage of treated PVs with documented PVI at the remapping procedure |
| Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia | 12 months | Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of \> 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor |
Countries
Czechia
Contacts
CONTACTVikramaditya Mediratta, MS
CONTACTTine Wouters
Outcome results
None listed