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The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).
This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 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 Ablation System Plus | Experimental | Ablation using the FARAPULSE Ablation System Plus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation to treat paroxysmal atrial fibrillation | Device | A pulmonary vein isolation will be performed using catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events | Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period. | 7 days to12 Months |
| Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure. | 12 months |
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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 PAF
Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Patient participation requirements:
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 ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
Any of the following cardiac procedures, implants or conditions:
Any of the following cardiovascular procedures, implants, or conditions:
a. Within the 3 months preceding enrollment:
i. Myocardial infarction
ii. Unstable angina
iii. Percutaneous coronary intervention
iv. Treatment with amiodarone
b. Within the 6 months preceding enrollment:
i. Heart surgery
ii. Stroke or TIA
iii. Any thromboembolic event
iv. Carotid stenting or endarterectomy
v. Pericarditis or pericardial effusion
c. Within the 12 months following enrollment:
i. Any likelihood of cardiac surgery or transplant
History of blood clotting or bleeding abnormalities.
Contraindication to, or unwillingness to use, systemic anticoagulation
Contraindications to both CT and MRI
Sensitivity to contrast media not controlled by premedication
Women of childbearing potential who are pregnant, lactating, not using birth control or planning to become pregnant during the anticipated study period
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
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| Name | Affiliation | Role |
|---|---|---|
| Ante Anic | University Hospital of Split | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Split | Split | Croatia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intent To Treat (ITT) | Enrolled subjects who undergo one or more ablation at the index procedure using the study device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent To Treat (ITT) | Enrolled subjects who undergo one or more ablation at the index procedure using the study device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events | Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period. | Posted | Count of Participants | Participants | 7 days to12 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 | FARAPULSE Endocardial Ablation | Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Tachycardia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher (Kit) Schneider | FARAPULSE | 617-686-7661 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2020 | Mar 29, 2023 | Prot_SAP_000.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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| 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 |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Time Between First Documented Atrial Fibrillation Diagnosis and Enrollment | Data unavailable for all 10 subjects | Mean | Standard Deviation | months |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 15 |
| 5 |
| 15 |
| 11 |
| 15 |
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
|
| Corona Virus Infection | Infections and infestations | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Vascular Access Complication | General disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |