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The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
The primary and secondary Safety, Feasibility, Effectiveness and Performance will be evaluated against pre-specified criteria as determined by the Sponsor and FDA. The criteria set in this study have been previously used to demonstrate Safety, Feasibility, Effectiveness and Performance in FARAPULSE Pulsed Field Ablation System for the treatment of Paroxysmal Atrial Fibrillation (PAF).
The analysis of the primary safety and performance objective will take place once all the subjects with a study FARAPULSE Pulsed field ablation procedure attempt have reached 12 months of follow-up post-pulsed field ablation procedure.
The analyses of the primary effectiveness objective will take place once all the subjects with a study pulsed field ablation procedure attempt have reached 34 ~ 36 months of follow-up post-pulsed field ablation procedure.
The analyses for the secondary objectives will take place once all subjects with a study pulsed field ablation procedure attempt have reached 34~36 months of follow-up post-pulsed field ablation procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Other | Ablation using the FARAPULSE Pulsed Field Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Device | A pulmonary vein isolation will be performed using catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure | 12 Months |
| Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months | To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD) | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE | Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event. | 12 Months |
| Additional Performance Analyses: Acute Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugee | Bruges | Belgium | ||||
| Jessa Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38385529 | Derived | Metzner A, Fiala M, Vijgen J, Ouss A, Gunawardene M, Hansen J, Kautzner J, Schmidt B, Duytschaever M, Reichlin T, Blaauw Y, Sommer P, Vanderper A, Achyutha AB, Johnson M, Raybuck JD, Neuzil P. Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study. Europace. 2024 Mar 1;26(3):euae053. doi: 10.1093/europace/euae053. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FARAPULSE Pulsed Field Ablation System | Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FARAPULSE Pulsed Field Ablation System | Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation |
| 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 | Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter | Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure | Modified Intent To Treat | Posted | Count of Participants | Participants | 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 | FARAPULSE Pulsed Field Ablation System | Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation |
| 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 |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Anderson | FARAPULSE | 651-582-5077 | Allison.Anderson@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 18, 2022 | Mar 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2020 | Mar 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing |
| 1 day |
| Hasselt |
| Belgium |
| Neuron Medical | Brno | Czechia |
| Nemocnice Na Homolce | Prague | 150 30 | Czechia |
| IKEM Cardiac Center | Prague | Czechia |
| Copenhagen(Gentofte) Hospital | Hellerup | 2900 | Denmark |
| Heart- and Diabetescenter NRW | Bad Oeynhausen | Germany |
| CCB Frankfurt | Frankfurt | 60431 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Asklepios-Hamburg,Germany | Hamburg | Germany |
| Catherina | Eindhoven | 5623 EJ | Netherlands |
| UMCG | Groningen | 9713 GZ | Netherlands |
| Inselspital - Bern | Bern | CH-3010 | Switzerland |
| 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 |
|
|
|
| Primary | Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months | To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD) | Modified Intent To Treat | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE | Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event. | Modified Intent To treat | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Secondary | Additional Performance Analyses: Acute Procedural Success | Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing | Modified Intent To Treat | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 1 |
| 180 |
| 25 |
| 180 |
| 9 |
| 180 |
| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
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| Appendicitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Vascular Psuedoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
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| Spinal Stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Papillary cystadenoma lymphomatosum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Stroke | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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