Trial Outcomes & Findings for The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation (NCT NCT05272852)

NCT ID: NCT05272852

Last Updated: 2025-01-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 30Days-12 months
• Results posted on: 2025-01-08

Participant Flow

Participant milestones

Measure	FARAPULSE™ Pulsed Field Ablation System Plus Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Overall Study STARTED	80
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using FARAPULSE™ Pulsed Field Ablation System Plus FARAPULSE™ Pulsed Field Ablation System Plus: Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Age, Categorical <=18 years	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=80 Participants
Age, Categorical >=65 years	54 Participants n=80 Participants
Age, Continuous	63.9 years STANDARD_DEVIATION 8.9 • n=80 Participants
Sex: Female, Male Female	28 Participants n=80 Participants
Sex: Female, Male Male	52 Participants n=80 Participants
Region of Enrollment Czechia	80 participants n=80 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using 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

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=77 Participants Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success	77 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
The Primary Safety Endpoint Assessed at 7 Days	1 Participants

SECONDARY outcome

Timeframe: 12 Months

Percentage of subjects with one or more device or procedure related SAEs.

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using 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
The Percentage of Subjects With a Device- or Procedure-related SAE Device Related Serious Adverse Events (SAEs)	0 Participants

SECONDARY outcome

Timeframe: 12 Months

The percentage of occurrence of stroke or TIA observed in any subjects

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
The Percentage of Subjects With Stroke or TIA	0 Participants

SECONDARY outcome

Timeframe: 12 Months

The percentage of subjects where cardioversion (s) was performed within the 12-month post index

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
The Percentage of Subjects Requiring Cardioversions	5 Participants

SECONDARY outcome

Timeframe: 12 Months

The percentage of subjects that were hospitalized for arrhythmia-related (AF, AFL or AT) reasons

Outcome measures

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 Participants Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization	0 Participants

Adverse Events

FARAPULSE™ Pulsed Field Ablation System Plus

Serious events: 14 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 participants at risk Ablation using FARAPULSE™ Pulsed Field Ablation System Plus FARAPULSE™ Pulsed Field Ablation System Plus: Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Blood and lymphatic system disorders Anemia	1.2% 1/80 • Number of events 1 • 12 months
Cardiac disorders Cardiac failure congestive	1.2% 1/80 • Number of events 1 • 12 months
Cardiac disorders Nodal rhythm	1.2% 1/80 • Number of events 1 • 12 months
Hepatobiliary disorders Cholecystitis	1.2% 1/80 • Number of events 1 • 12 months
Infections and infestations Pneumonia	1.2% 1/80 • Number of events 1 • 12 months
Infections and infestations Urinary tract infection	1.2% 1/80 • Number of events 2 • 12 months
Injury, poisoning and procedural complications Injury	1.2% 1/80 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.2% 1/80 • Number of events 1 • 12 months
Renal and urinary disorders Renal Failure	1.2% 1/80 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.2% 1/80 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Haemothorax	1.2% 1/80 • Number of events 1 • 12 months
Vascular disorders Arteriovenous fistula	2.5% 2/80 • Number of events 2 • 12 months
Vascular disorders Blood Pressure Fluctuation	1.2% 1/80 • Number of events 1 • 12 months

Other adverse events

Measure	FARAPULSE™ Pulsed Field Ablation System Plus n=80 participants at risk Ablation using FARAPULSE™ Pulsed Field Ablation System Plus FARAPULSE™ Pulsed Field Ablation System Plus: Ablation using FARAPULSE™ Pulsed Field Ablation System Plus
Cardiac disorders Arteriospasm coronary	18.8% 15/80 • Number of events 15 • 12 months
Cardiac disorders Atrial tachycardia	2.5% 2/80 • Number of events 2 • 12 months
Cardiac disorders Atrioventricular block second degree	1.2% 1/80 • Number of events 1 • 12 months
Gastrointestinal disorders Colitis	1.2% 1/80 • Number of events 1 • 12 months
Infections and infestations COVID-19	1.2% 1/80 • Number of events 1 • 12 months
Infections and infestations Cellulitis	1.2% 1/80 • Number of events 1 • 12 months
Infections and infestations Infection	1.2% 1/80 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Synovial cyst	1.2% 1/80 • Number of events 1 • 12 months
Nervous system disorders Syncope	1.2% 1/80 • Number of events 1 • 12 months
Vascular disorders Embolism	1.2% 1/80 • Number of events 1 • 12 months
Vascular disorders Haematoma	12.5% 10/80 • Number of events 10 • 12 months
Vascular disorders Haemorrhage	2.5% 2/80 • Number of events 2 • 12 months
Vascular disorders Peripheral artery stenosis	1.2% 1/80 • Number of events 1 • 12 months

Additional Information

Karin Froidcourt

BostonScientific

Phone: +0032471636566

Email: Karin.Froidcourt@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place