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The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:
Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?
Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FARAFLEX Mapping and Pulsed Field Ablation (PFA) System | Experimental | Participants undergo a catheter procedure using the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System to treat atrial fibrillation. The catheter is used to map the heart's electrical signals and deliver pulsed field ablation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAFLEX Mapping and Pulsed Field Ablation (PFA) System | Device | Catheter used to perform cardiac electrophysiological mapping and deliver cardiac tissue ablation therapy for the treatment of Atrial Fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure. | Occurrence of defined Composite Serious Adverse Events after the procedure through Day 60. | After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60 |
| The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment. | Acute Procedural Success defined as Pulmonary Vein (PV) Isolation and Chronic Success. Chronic Success is defined as freedom from the following after the Blanking Period (60 days):
| Day 0 through the Day 365 Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Arrhythmia Burden Success Endpoint | Atrial Arrhythmia Burden Success is defined as the proportion of Treatment subjects with atrial arrhythmia burden less than or equal to 0.1% in the time period post-blanking period through 6 months, as measured by LUX-Dx. | Post-blanking period (Day 60) through 6 months (Day 180) |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following atrial conditions:
Any of the following cardiovascular conditions:
History of sustained ventricular tachycardia or ventricular fibrillation
Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)
Presence of any of the following cardiac devices or implants:
Clinically significant valvular disease, including:
Hypertrophic or amyloid cardiomyopathy
Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access
Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)
Severe right ventricular dysfunction per investigator assessment
Any of the following congenital conditions:
Any of the following medical history conditions:
Any of the following baseline conditions:
Any of the following events within 90 days prior to consent:
Other conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madalyn MacKinnon | Contact | 860-992-2724 | Madalyn.MacKinnon@bsci.com | |
| Sara Veraghtert | Contact | Sara.Veraghtert@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Research | Recruiting | Austin | Texas | 78705 | United States |
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|
| Cavo-Tricuspid Isthmus (CTI) Ablation - Acute Procedural Endpoint |
Defined as the proportion of Treatment Subjects who underwent a Cavo-Tricuspid Isthmus (CTI) ablation during the Index Procedure, regardless of the atrial fibrillation cohort, with absence of conduction through the cavo-tricuspid isthmus in both directions (bidirectional block), achieved with the FARAFLEX™ Mapping and PFA Catheter only, and confirmed prior to the end of the Index Ablation Procedure. |
| Index Ablation Procedure |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004864 | Equipment and Supplies |
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