Trial Outcomes & Findings for Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II) (NCT NCT05152966)

Results Overview

Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

7 days

Results posted on

2024-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	FARAPULSE™ Endocardial Cardiac Ablation Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

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 Cardiac Ablation n=20 Participants Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=20 Participants
Age, Categorical >=65 years	9 Participants n=20 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 9 • n=20 Participants
Sex: Female, Male Female	5 Participants n=20 Participants
Sex: Female, Male Male	15 Participants n=20 Participants
Region of Enrollment Czechia	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 7 days

Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(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.

Outcome measures

Outcome measures
Measure	FARAPULSE™ Endocardial Cardiac Ablation n=20 Participants Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs	0 participants

PRIMARY outcome

Timeframe: 12 Months

Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEsEndpoint(CSE) defined as the incidence of the following late-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC).

Outcome measures

Outcome measures
Measure	FARAPULSE™ Endocardial Cardiac Ablation n=20 Participants Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs	0 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

Outcome measures
Measure	FARAPULSE™ Endocardial Cardiac Ablation n=20 Participants Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Acute Procedural Success; Acute Vein Succes	20 participants

Adverse Events

FARAPULSE™ Endocardial Cardiac Ablation

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	FARAPULSE™ Endocardial Cardiac Ablation n=20 participants at risk Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Cardiac disorders Pericardial Effusion	10.0% 2/20 • Number of events 2 • 12 months
Cardiac disorders Cardiac Tamponade	5.0% 1/20 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	FARAPULSE™ Endocardial Cardiac Ablation n=20 participants at risk Ablation using FARAPULSE™ Cardiac Ablation System Plus Ablation: Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Vascular disorders Hematoma	10.0% 2/20 • Number of events 2 • 12 months
Vascular disorders AV Fistula	5.0% 1/20 • Number of events 1 • 12 months
Cardiac disorders Arteriosclerosis Coronary Artery	5.0% 1/20 • Number of events 1 • 12 months

Additional Information

Christopher (Kit) Schneider

FARAPULSE

Phone: 6176867661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place