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 Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL
Detailed description
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.
Interventions
DEVICEAblation
Ablation using the FARAPULSE™ Cardiac 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
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 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 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 |
|---|---|---|
| Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | 7 days | 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. |
| Acute Procedural Success; Acute Vein Succes | 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) |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation Ablation using FARAPULSE™ Cardiac Ablation System Plus
Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | FARAPULSE™ Endocardial Cardiac Ablation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 9 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 20 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
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)
Time frame: Index Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation | Acute Procedural Success; Acute Vein Succes | 20 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 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.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation | Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | 0 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).
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE™ Endocardial Cardiac Ablation | Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs | 0 Participants |