Trial Outcomes & Findings for PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation (NCT NCT04170608)

Last Updated: 2022-05-04

Results Overview

Number of patients with death, MI, diaphragmatic paralysis, stroke/TIA, thromboemolism, pericarditis, tamponade/perforation, vascular access complications, hospitalization, heart block, PV stenosis, atrioesophageal fistula.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

30 Days

Results posted on

2022-05-04

Participant Flow

A total of 10 subjects consented and were treated.

A total of 10 patients were enrolled (signed informed consent) and 10 subjects were treated at two (2) sites in Europe.

Participant milestones

Participant milestones
Measure	FARAPULSE Endocardial Ablation Ablation using the FARAPULSE Endocardial Multi Ablation System FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FARAPULSE Endocardial Ablation n=10 Participants Ablation using the FARAPULSE Endocardial Multi Ablation System FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System
Age, Continuous	56.0 years STANDARD_DEVIATION 14.2 • n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Region of Enrollment Czechia	5 participants n=10 Participants
Region of Enrollment Croatia	5 participants n=10 Participants
Body Mass Index	26.9 kg/m^2 STANDARD_DEVIATION 3.3 • n=10 Participants
Left Atrial Diameter	3.9 cm STANDARD_DEVIATION 0.4 • n=10 Participants
AF History (number of months)	20.98 Months STANDARD_DEVIATION 0.1 • n=10 Participants
LVEF %	61.9 Percentage of Left ventricular ejection STANDARD_DEVIATION 5.0 • n=10 Participants
CHA2DS2VASC	1.8 units on a scale STANDARD_DEVIATION 1.7 • n=10 Participants
Patient that failed any AntiArrhythmic Drugs	10 Participants n=10 Participants
Smoking	1 Participants n=10 Participants
Dyslipidemia	3 Participants n=10 Participants
COPD	0 Participants n=10 Participants
Pace Maker/Implantable Cardioverter Defibrillator	0 Participants n=10 Participants
Unstable angina	0 Participants n=10 Participants
NYHA Heart Failure Class I	0 Participants n=10 Participants
NYHA Heart Failure Class II	3 Participants n=10 Participants
NYHA Heart Failure Class III	0 Participants n=10 Participants
NYHA Heart Failure Class IV	0 Participants n=10 Participants
Any History of Structural heart disease	0 Participants n=10 Participants
Cerebrovascular disease	1 Participants n=10 Participants
Cardiac Surgery	0 Participants n=10 Participants
Diabetes	1 Participants n=10 Participants
Hypertension	6 Participants n=10 Participants
Hyperthyroidism	0 Participants n=10 Participants
Hypothyroidism	3 Participants n=10 Participants
Myocardial infarction	0 Participants n=10 Participants
Peripheral vascular disease	0 Participants n=10 Participants
Pulmonary hypertension	0 Participants n=10 Participants
Renal dysfunction/failure	1 Participants n=10 Participants
Sleep apnea	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Outcome measures
Measure	FARAPULSE Endocardial Ablation n=10 Participants Ablation using the FARAPULSE Endocardial Multi Ablation System FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System
Safety: Number of Participants With Prespecified Primary Safety Events Within 30 Days of Index Procedure.	0 Participants

PRIMARY outcome

Timeframe: Index Procedure

The primary feasibility endpoint for this study is the proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Multi Ablation System during the first Procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.

Outcome measures

Outcome measures
Measure	FARAPULSE Endocardial Ablation n=10 Participants Ablation using the FARAPULSE Endocardial Multi Ablation System FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System
Feasibility: Acute Key Procedural Success	1.0 Proportion of subjects

Adverse Events

FARAPULSE Endocardial Ablation

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FARAPULSE Endocardial Ablation n=10 participants at risk Ablation using the FARAPULSE Endocardial Multi Ablation System FARAPULSE Endocardial Multi Ablation System: Ablation using the FARAPULSE Endocardial Multi Ablation System
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • 1 year
Nervous system disorders Paraesthesia	10.0% 1/10 • Number of events 1 • 1 year
General disorders Injection site inflammation	10.0% 1/10 • Number of events 1 • 1 year
General disorders Oedema Peripheral	10.0% 1/10 • Number of events 1 • 1 year
Vascular disorders Haematoma	20.0% 2/10 • Number of events 2 • 1 year
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • Number of events 1 • 1 year
Blood and lymphatic system disorders Cardiac Disorders	10.0% 1/10 • Number of events 1 • 1 year
Blood and lymphatic system disorders Palpitations	10.0% 1/10 • Number of events 1 • 1 year
Cardiac disorders Sinus Arrest	10.0% 1/10 • Number of events 1 • 1 year
Gastrointestinal disorders Gastrointestinal Tract Irritation	10.0% 1/10 • Number of events 1 • 1 year
Infections and infestations Urinary Tract Infection	10.0% 1/10 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Back Pain	10.0% 1/10 • Number of events 1 • 1 year

Additional Information

Christopher Schneider

FARAPULSE

Phone: 617-686-7661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place