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The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) in a Chinese population.
The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only.
The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure.
Primary endpoints analysis is planned to be conducted after all enrolled subjects have completed data collection at 1-month follow-up visit. All the subjects underwent study device treatment will be followed up to 12 months after the procedure, and the secondary and other endpoints will be analyzed then.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Device | Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Procedural Success | The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only. | Day 0 |
| Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure | The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure. | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.
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| Name | Affiliation | Role |
|---|---|---|
| Minglong Chen, Dr | Boao Super Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boao Super Hospital | Bo'ao | Hainan | 571434 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | FARAPULSE Pulsed Field Ablation System | Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation. FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FARAPULSE Pulsed Field Ablation System | Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation. FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System. |
| 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 | Number of Participants With Acute Procedural Success | The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only. | Posted | Count of Participants | Participants | Day 0 |
|
|
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 | Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation. FARAPULSE Pulsed Field Ablation System: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial injury | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Xiuyue Jia | Boston Scientific | +86 15104673346 | xiuyue.jia@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 | Jun 15, 2022 | Oct 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2023 | Oct 31, 2024 | 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Full Range | cm |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| Weight | Mean | Full Range | Kg |
|
| Participants |
|
|
| Primary | Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure | The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure. | Posted | Count of Participants | Participants | 7 Days |
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| 20 |
| 30 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Arteriospasm coronary | Cardiac disorders | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Puncture site haematoma | General disorders | Systematic Assessment |
|
| Catheter site haematoma | General disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Puncture site pain | General disorders | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood glucose increased | Investigations | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |