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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 Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL
This 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 |
|---|---|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation | Experimental | Ablation using FARAPULSE™ Cardiac Ablation System Plus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Ablation using the FARAPULSE™ Cardiac Ablation System Plus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(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. | 7 days |
| Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). | 12 Months |
| Acute Procedural Success; Acute Vein Succes | 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 |
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Key Inclusion Criteria: Patients are required to meet all the following inclusion criteria to participate in this study:
Age 18-75 Patients with documented drug-resistant symptomatic persistent AF
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce | Prague | Czechia |
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| ID | Title | Description |
|---|---|---|
| FG000 | FARAPULSE™ Endocardial Cardiac Ablation | Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FARAPULSE™ Endocardial Cardiac Ablation | Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac 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 | Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(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. | Posted | Number | participants | 7 days |
|
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 | FARAPULSE™ Endocardial Cardiac Ablation | Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher (Kit) Schneider | FARAPULSE | 6176867661 | christopher.schneider@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2022 | Nov 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2023 | Nov 30, 2023 | 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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| 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 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Primary | Acute Procedural Success; Acute Vein Succes | 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 | Number | participants | Index Procedure |
|
|
|
| 1 |
| 20 |
| 3 |
| 20 |
| 4 |
| 20 |
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
|
| AV Fistula | Vascular disorders | Systematic Assessment |
|
| Arteriosclerosis Coronary Artery | Cardiac disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |