Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.
Sponsors
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment; 2. Subjects whose preoperative diagnosis is PAF confirmed by the clinician; 3. De novo ablation procedure for PAF with Class I or IIa recommendations\* according to 2018 Chinese expert consensus on atrial fibrillation therapy; 4. Subjects who are able and willing to provide the defined observational data and/or participate in baseline and follow-up evaluations for the full study; 5. Subjects who are willing and capable of providing informed consent.
Exclusion criteria
1. Subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure; 2. Women of childbearing potential who are, or plan to become, pregnant during the time of the study; 3. Subjects with any known contraindication to AF ablation with FARAPULSE Pulsed Field Ablation system, anticoagulation therapy, or contrast media in the judgment of the investigator or subjects unwillingness to use systemic anticoagulation 4. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Procedural Success | Day 0 | 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. |
| Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure | 7 Days | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | FARAPULSE Pulsed Field Ablation System |
|---|---|
| Age, Continuous | 57.6 years |
| BMI | 25.3 kg/m^2 |
| Height | 165.4 cm |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 30 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
| Weight | 70 Kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 20 / 30 |
| serious Total, serious adverse events | 4 / 30 |
Outcome results
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.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Number of Participants With Acute Procedural Success | 30 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.
Time frame: 7 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FARAPULSE Pulsed Field Ablation System | Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure | 0 Participants |