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The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL
PersAFOne III study is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FARAPULSEâ„¢ Pulsed Field Ablation System Plus | Experimental | Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSEâ„¢ Pulsed Field Ablation System Plus | Device | Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMC | Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 30 days of an Index or Remap Procedure)
| 30Days-12 months |
| Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success | Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure) | Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Safety Endpoint Assessed at 7 Days | Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 7 days of an Index or Remap Procedure)
|
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Inclusion Criteria:
Study subjects are required to meet all the following inclusion criteria to participate in this study:
Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Patient participation requirements:
Lives locally
Is willing and capable of providing Informed Consent to undergo study procedures
Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study
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Exclusion Criteria:
Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
AF that is:
Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
Any of the following cardiac procedures, implants or conditions:
Any of the following within 3 months prior toenrollment:
History of blood clotting or bleeding abnormalities.
Contraindication to, or unwillingness to use, systemic anticoagulation
Contraindications to CT or MRI
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating or not using birth control
Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to
Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
Current or anticipated enrollment in any other clinical study
Employment by FARAPULSE or the same hospital department or office of any investigator, or a family member of any of the preceding groups.
Use of amiodarone after day of index ablation procedure. Patients will cease use of amiodarone on or before the date of the index ablation procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Petr Neuzil | Nemocnice Na Homolce (homolka) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuron Medical | Brno | 637 00 | Czechia | |||
| Nemocnice Na Homolce |
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| ID | Title | Description |
|---|---|---|
| FG000 | FARAPULSEâ„¢ Pulsed Field Ablation System Plus | Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FARAPULSEâ„¢ Pulsed Field Ablation System Plus | Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus FARAPULSEâ„¢ Pulsed Field Ablation System Plus: Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMC | Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 30 days of an Index or Remap Procedure)
| Posted | Count of Participants | Participants | 30Days-12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FARAPULSEâ„¢ Pulsed Field Ablation System Plus | Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus FARAPULSEâ„¢ Pulsed Field Ablation System Plus: Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriospasm coronary | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karin Froidcourt | BostonScientific | +0032471636566 | Karin.Froidcourt@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2022 | Nov 14, 2024 | Prot_SAP_001.pdf |
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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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| 7-Days |
| The Percentage of Subjects With a Device- or Procedure-related SAE | Percentage of subjects with one or more device or procedure related SAEs. | 12 Months |
| The Percentage of Subjects With Stroke or TIA | The percentage of occurrence of stroke or TIA observed in any subjects | 12 Months |
| The Percentage of Subjects Requiring Cardioversions | The percentage of subjects where cardioversion (s) was performed within the 12-month post index | 12 Months |
| The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization | The percentage of subjects that were hospitalized for arrhythmia-related (AF, AFL or AT) reasons | 12 Months |
| Prague |
| Czechia |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | FARAPULSEâ„¢ Pulsed Field Ablation System Plus | Ablation using FARAPULSEâ„¢ Pulsed Field Ablation System Plus |
|
|
| Primary | Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success | Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure) | Posted | Count of Participants | Participants | Index Procedure |
|
|
|
| Secondary | The Primary Safety Endpoint Assessed at 7 Days | Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up. Early onset (within 7 days of an Index or Remap Procedure)
| Posted | Count of Participants | Participants | 7-Days |
|
|
|
| Secondary | The Percentage of Subjects With a Device- or Procedure-related SAE | Percentage of subjects with one or more device or procedure related SAEs. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | The Percentage of Subjects With Stroke or TIA | The percentage of occurrence of stroke or TIA observed in any subjects | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | The Percentage of Subjects Requiring Cardioversions | The percentage of subjects where cardioversion (s) was performed within the 12-month post index | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization | The percentage of subjects that were hospitalized for arrhythmia-related (AF, AFL or AT) reasons | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 0 |
| 80 |
| 14 |
| 80 |
| 38 |
| 80 |
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | Systematic Assessment |
|
| Blood Pressure Fluctuation | Vascular disorders | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Embolism | Vascular disorders | Systematic Assessment |
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| Haematoma | Vascular disorders | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | Systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |