Trial Outcomes & Findings for A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation (NCT NCT04474054)

Results Overview

Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

7 days to12 Months

Results posted on

2023-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Intent To Treat (ITT) Enrolled subjects who undergo one or more ablation at the index procedure using the study device.
Overall Study STARTED	15
Overall Study COMPLETED	15
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	Intent To Treat (ITT) n=15 Participants Enrolled subjects who undergo one or more ablation at the index procedure using the study device.
Age, Continuous	58.3 years STANDARD_DEVIATION 13.2 • n=15 Participants
Sex: Female, Male Female	6 Participants n=15 Participants
Sex: Female, Male Male	9 Participants n=15 Participants
Region of Enrollment Croatia	15 Participants n=15 Participants
Body Mass Index	27.3 kg/m2 STANDARD_DEVIATION 3.8 • n=15 Participants
Time Between First Documented Atrial Fibrillation Diagnosis and Enrollment	12.2 months STANDARD_DEVIATION 11.1 • n=5 Participants • Data unavailable for all 10 subjects

PRIMARY outcome

Timeframe: 7 days to12 Months

Includes serious adverse events which are device- or procedure-related, and as define din Composite Safety Endpoint definition table occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.

Outcome measures

Outcome measures
Measure	FARAPULSE Endocardial Ablation n=15 Participants Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events	0 Participants

PRIMARY outcome

Timeframe: 12 months

Includes both acute procedural success (successful electrical isolation of set of lesions around the ostia of all pulmonary veins) and therapeutic success (Re-treatment for AF with ablation using study devices, or if necessary, a commercially approved ablation device after a 3 month blanking period constitute a treatment failure.

Outcome measures

Outcome measures
Measure	FARAPULSE Endocardial Ablation n=15 Participants Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter	10 Participants

Adverse Events

FARAPULSE Endocardial Ablation

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FARAPULSE Endocardial Ablation n=15 participants at risk Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Cardiac disorders Atrial Tachycardia	13.3% 2/15 • Number of events 2 • 12 Months
Cardiac disorders Supraventricular Tachycardia	13.3% 2/15 • Number of events 2 • 12 Months
Nervous system disorders Transient Ischemic Attack	6.7% 1/15 • Number of events 1 • 12 Months

Other adverse events

Other adverse events
Measure	FARAPULSE Endocardial Ablation n=15 participants at risk Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation. FARAPULSE Endocardial Ablation System: Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Surgical and medical procedures Hospitalization	26.7% 4/15 • Number of events 4 • 12 Months
Infections and infestations Corona Virus Infection	13.3% 2/15 • Number of events 2 • 12 Months
Cardiac disorders Supraventricular Tachycardia	6.7% 1/15 • Number of events 1 • 12 Months
General disorders Vascular Access Complication	26.7% 4/15 • Number of events 4 • 12 Months
Vascular disorders Hypertension	6.7% 1/15 • Number of events 1 • 12 Months

Additional Information

Christopher (Kit) Schneider

FARAPULSE

Phone: 617-686-7661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place