Trial Outcomes & Findings for The FARAPULSE FARA-Freedom Trial (NCT NCT05072964)

NCT ID: NCT05072964

Last Updated: 2024-10-17

Results Overview

Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD). Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2024-10-17

Participant Flow

Participant milestones

Measure	FARAPULSE Pulsed Field Ablation System Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Overall Study STARTED	180
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	FARAPULSE Pulsed Field Ablation System Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Overall Study Withdrawal by Subject	4
Overall Study Death	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	FARAPULSE Pulsed Field Ablation System n=180 Participants Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Age, Categorical <=18 years	0 Participants n=180 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=180 Participants
Age, Categorical >=65 years	80 Participants n=180 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 10.1 • n=180 Participants
Sex: Female, Male Female	70 Participants n=180 Participants
Sex: Female, Male Male	110 Participants n=180 Participants
Region of Enrollment Netherlands	18 participants n=180 Participants
Region of Enrollment Belgium	28 participants n=180 Participants
Region of Enrollment Czechia	63 participants n=180 Participants
Region of Enrollment Denmark	12 participants n=180 Participants
Region of Enrollment Switzerland	9 participants n=180 Participants
Region of Enrollment Germany	50 participants n=180 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Modified Intent To Treat

Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one Antiarrhythmic Drugs (AAD).

Includes both acute procedural success ( Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or or rescheduled index Procedure

Outcome measures

Measure	FARAPULSE Pulsed Field Ablation System n=180 Participants Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure Through 12 Months and Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	121 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Modified Intent To Treat

To demonstrate safety of FARAPULSE Pulsed Field Ablation System, by assessing the rate of subjects experiencing Early and Late onset Composite Safety Endpoints(CSE) with paroxysmal atrial fibrillation who have therapeutic failure of at least one AntiArrhythmic Drug (AAD)

Outcome measures

Measure	FARAPULSE Pulsed Field Ablation System n=180 Participants Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Safety: Percentage of Participants Experiencing Composite Safety Endpoint(CSE) Through 12 Months	2 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Modified Intent To treat

Freedom from a serious adverse event (SAE) which has not been categorized as a Pulsed Field Ablation procedure event.

Outcome measures

Measure	FARAPULSE Pulsed Field Ablation System n=180 Participants Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE Participants free from any of the procedure related SAE	173 Participants
Additional Safety Analyses: Percentage of Participants Free From Any of the Device or Procedure Related SAE Participants free from any of the device related SAE	179 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Modified Intent To Treat

Acute Procedural success is the demonstration of Acute Vein Success (measured by % subjects) was determined by Isolation of an ablated PVI using the FARAPULSE Pulsed Field Ablation System during the first ablation procedure (Index or Rescheduled Index Procedure), as clinically assessed by entrance block demonstrated ≥ 20 minutes after the last PVI lesion is made with or without adenosine testing

Outcome measures

Measure	FARAPULSE Pulsed Field Ablation System n=180 Participants Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Additional Performance Analyses: Acute Procedural Success	180 Participants

Adverse Events

FARAPULSE Pulsed Field Ablation System

Serious events: 25 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	FARAPULSE Pulsed Field Ablation System n=180 participants at risk Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Blood and lymphatic system disorders Anemia	1.1% 2/180 • Number of events 2 • 12 months
Cardiac disorders Angina pectoris	0.56% 1/180 • Number of events 1 • 12 months
Cardiac disorders Atrial Fibrillation	2.8% 5/180 • Number of events 9 • 12 months
Cardiac disorders Atrial Flutter	0.56% 1/180 • Number of events 3 • 12 months
Cardiac disorders Atrial tachycardia	1.1% 2/180 • Number of events 2 • 12 months
Cardiac disorders Cardiac tamponade	0.56% 1/180 • Number of events 1 • 12 months
Cardiac disorders Coronary artery disease	0.56% 1/180 • Number of events 1 • 12 months
Gastrointestinal disorders Abdominal pain	0.56% 1/180 • Number of events 1 • 12 months
Gastrointestinal disorders Dyspepsia	0.56% 1/180 • Number of events 1 • 12 months
General disorders Chest Pain	0.56% 1/180 • Number of events 1 • 12 months
Hepatobiliary disorders Cholecystitis	0.56% 1/180 • Number of events 1 • 12 months
Infections and infestations Appendicitis	0.56% 1/180 • Number of events 1 • 12 months
Infections and infestations Pneumonia	1.1% 2/180 • Number of events 2 • 12 months
Injury, poisoning and procedural complications Vascular Psuedoaneurysm	0.56% 1/180 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.56% 1/180 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.56% 1/180 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.56% 1/180 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.56% 1/180 • Number of events 1 • 12 months
Nervous system disorders Stroke	0.56% 1/180 • Number of events 1 • 12 months
Nervous system disorders Syncope	0.56% 1/180 • Number of events 1 • 12 months
Nervous system disorders Transient ischaemic attack	1.1% 2/180 • Number of events 2 • 12 months
Reproductive system and breast disorders Benign prostatic hyperplasia	0.56% 1/180 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.56% 1/180 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.56% 1/180 • Number of events 1 • 12 months
Vascular disorders Hypertension	0.56% 1/180 • Number of events 1 • 12 months

Other adverse events

Measure	FARAPULSE Pulsed Field Ablation System n=180 participants at risk Ablation using the FARAPULSE Pulsed Field Ablation System FARAPULSE Pulsed Field Ablation System: A pulmonary vein isolation will be performed using catheter ablation
Cardiac disorders Atrial Fibrillation	5.0% 9/180 • Number of events 16 • 12 months

Additional Information

Allison Anderson

FARAPULSE

Phone: 651-582-5077

Email: Allison.Anderson@bsci.com

Results disclosure agreements

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