Persistent Atrial Fibrillation
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEFARAPULSE™ Pulsed Field Ablation System Plus
Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Study subjects are required to meet all the following inclusion criteria to participate in this study: 1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria: 1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent. 2. ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days 3. Holter within 90 days prior to the Enrollment Date demonstrating 24 hours of continuous AF 2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment. 3. Patient participation requirements: 1. Lives locally 2. Is willing and capable of providing Informed Consent to undergo study procedures 3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study \-
Exclusion criteria
Subjects will be excluded from participating in this study if they meet any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30Days-12 months | 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) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula |
| Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success | Index Procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With Stroke or TIA | 12 Months | The percentage of occurrence of stroke or TIA observed in any subjects |
| The Primary Safety Endpoint Assessed at 7 Days | 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) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula |
| The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization | 12 Months | The percentage of subjects that were hospitalized for arrhythmia-related (AF, AFL or AT) reasons |
| The Percentage of Subjects Requiring Cardioversions | 12 Months | The percentage of subjects where cardioversion (s) was performed within the 12-month post index |
| The Percentage of Subjects With a Device- or Procedure-related SAE | 12 Months | Percentage of subjects with one or more device or procedure related SAEs. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
FARAPULSE™ Pulsed Field Ablation System Plus: Ablation using FARAPULSE™ Pulsed Field Ablation System Plus | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | FARAPULSE™ Pulsed Field Ablation System Plus | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 54 Participants | — |
| Age, Categorical Between 18 and 65 years | 26 Participants | — |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 8.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 80 participants | — |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 52 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 38 / 80 |
| serious Total, serious adverse events | 14 / 80 |
Outcome results
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)
Time frame: Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success | 77 Participants |
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) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula
Time frame: 30Days-12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | 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 | 1 Participants |
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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization | 0 Participants |
Secondary
The Percentage of Subjects Requiring Cardioversions
The percentage of subjects where cardioversion (s) was performed within the 12-month post index
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | The Percentage of Subjects Requiring Cardioversions | 5 Participants |
Secondary
The Percentage of Subjects With a Device- or Procedure-related SAE
Percentage of subjects with one or more device or procedure related SAEs.
Time frame: 12 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | The Percentage of Subjects With a Device- or Procedure-related SAE | Device Related Serious Adverse Events (SAEs) | 0 Participants |
| FARAPULSE™ Pulsed Field Ablation System Plus | The Percentage of Subjects With a Device- or Procedure-related SAE | Procedure Related Serious Adverse Events (SAEs) | 3 Participants |
Secondary
The Percentage of Subjects With Stroke or TIA
The percentage of occurrence of stroke or TIA observed in any subjects
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | The Percentage of Subjects With Stroke or TIA | 0 Participants |
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) * Death * Myocardial infarction (MI) * Persistent diaphragmatic paralysis * Stroke or transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Pericarditis * Cardiac tamponade / perforation * Vascular access complications requiring intervention * Heart block Late onset (any time during follow-up through 12 months) * Pulmonary vein (PV) stenosis (\> 70% diameter reduction from baseline) * Atrio-esophageal fistula
Time frame: 7-Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Pulsed Field Ablation System Plus | The Primary Safety Endpoint Assessed at 7 Days | 1 Participants |