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This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).
The objective of this feasibility study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FARAPULSE⢠Pulsed Field Ablation (PFA) System | Other | Single Arm Prospective |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSE⢠Pulsed Field Ablation (PFA) System | Device | The FARAWAVE⢠PFA Catheter will be used to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARASTAR⢠Generator will be used in conjunction with the FARAWAVE⢠PFA Catheter to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARADRIVE⢠Steerable Sheath will be used for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum. |
| Measure | Description | Time Frame |
|---|---|---|
| Device or procedure-related Composite Adverse Events (CAEs) | The incidence of device or procedure-related Composite Adverse Events (CAEs) following the Index Procedure will be evaluated. | Ablation Procedure Day 0 - Day 7; Day 0 - Day 30; Day 0 - Day 60 |
| Acute Procedural Success | The proportion of subjects with percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PV) and posterior wall (PW) during the Index Procedure, as clinically assessed by entrance and/or exit block or confirmed by electroanatomic mapping. | During the Ablation Procedure |
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Inclusion Criteria:
ā„ 18 years of age, or older if required by local law
Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation
Persistent AF Documented:
OR
Paroxysmal AF Documented:
Willing and capable of providing informed consent
Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Exclusion Criteria:
Atrial exclusions - any of the following atrial conditions:
Cardiovascular Conditions - Any of the following cardiovascular conditions:
History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
Cardiac Devices and Implants:
Valvular Disease - Presence of any of the following:
Cardiomyopathy - Hypertrophic cardiomyopathy
Access Issues - Any IVC filter, known inability to obtain vascular access, or other contraindication to femoral access
Anticipated Cardiac Surgery - Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
Congenital Conditions - Any of the following congenital conditions:
a. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
Baseline Conditions - Any of the following conditions at Baseline:
Any of the following events within 90 days of the Consent Date:
Medical History - Any of the following conditions in the Medical History
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandon Shuler | Contact | +1 701 220 1710 | brandon.shuler1@bsci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinicki Bolnicki Centar Split | Recruiting | Split | 21 000 | Croatia |
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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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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Na Homolce Hospital | Recruiting | Prague | 15030 | Czechia |
|
| Queen Mary Hospital | Not yet recruiting | Hong Kong | Hong Kong |
|
| Taipei Veterans General Hospital-Hospital | Not yet recruiting | Taipei | 1127 | Taiwan |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |