NCT05113056

Brief Summary

The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

October 28, 2021

Last Update Submit

November 9, 2023

Conditions

Atrial ArrhythmiaAtrial Fibrillation

Keywords

atrial fibrillationablationpulsed field ablation (PFA)

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects who are free from device/procedure related Major Adverse Events

    The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.

    6 months

  • Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)

    The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device

    20 minutes post ablation

Secondary Outcomes (2)

  • Analysis of all identified SAEs, SADEs, and UADEs

    12 months

  • Subjects with freedom from an atrial arrhythmia

    12 months

Study Arms (1)

Non-randomized

EXPERIMENTAL

All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation.

Device: Acutus Medical Pulsed Field Ablation System

Interventions

Acutus Medical Pulsed Field Ablation SystemDEVICE

All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.

Non-randomized

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between the ages of 18 to 80 years at time of consent
  • Clinically indicated and scheduled for a de novo catheter ablation of AF
  • Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.

You may not qualify if:

  • In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
  • Continuous episodes of AF duration lasting longer than 12-months
  • Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
  • Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
  • Structural heart disease or cardiac history as described below:
  • Left ventricular ejection fraction (LVEF) \< 35%
  • Left atrial size \> 60 mm
  • Evidence of heart failure (NYHA Class III or IV)
  • Unstable angina or ongoing myocardial ischemia
  • Recent myocardial infarction
  • Severe uncontrolled systemic hypertension
  • Moderate or severe valvular heart disease (stenosis or regurgitation).
  • Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
  • l. Presence of a left atrial appendage occlusion device. j. Previous PV stenting or evidence of PV stenosis.
  • Body Mass Index (BMI) \> 42 kg/m2
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Na Homolce Hospital

Prague, 150 30, Czechia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Petr Neuzil, MD

    Na Homolce Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo ablation for atrial fibrillation.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 9, 2021

Study Start

November 11, 2021

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

CZ(1)