NCT04170621

Brief Summary

PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation

Trial Health

90
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
2 countries

2 active sites

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 17, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

October 17, 2019

Results QC Date

January 8, 2024

Last Update Submit

January 8, 2024

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Safety at 30 Days

    Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula

    30 Days

Study Arms (1)

FARAPULSE Endocardial Ablation

EXPERIMENTAL

Ablation using the FARAPULSE Endocardial Multi Ablation System

Device: Ablation

Interventions

AblationDEVICE

Ablation using the FARAPULSE Endocardial Multi Ablation System

FARAPULSE Endocardial Ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
  • Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
  • ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
  • Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
  • Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
  • Patient participation requirements:
  • Lives locally
  • Is willing and capable of providing Informed Consent to undergo study procedures
  • Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if:

  • AF that is:
  • Paroxysmal (longest AF episode \< 7days)
  • Longstanding (has persisted \> 12 months or that does not respond to cardioversion if \< 12 months)
  • Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
  • Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
  • Any of the following cardiac procedures, implants or conditions:
  • Clinically significant arrhythmias other than AF, AFL or AT
  • Hemodynamically significant valvular disease
  • Prosthetic heart valve
  • NYHA Class III or IV CHF
  • Previous endocardial or epicardial ablation or surgery for AF
  • Atrial or ventricular septal defect closure
  • Atrial myxoma
  • Left atrial appendage device or occlusion
  • Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Split

Split, 21000, Croatia

Location

Nemocnice Na Homolce

Prague, Czechia

Location

Related Publications (1)

  • Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T, Sikiric I, Dukkipati SR, Kawamura I, Neuzil P. Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation. J Am Coll Cardiol. 2020 Sep 1;76(9):1068-1080. doi: 10.1016/j.jacc.2020.07.007.

    PMID: 32854842DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christopher (Kit) Schneider
Organization
FARAPULSE
christopher.schneider@bsci.com
6176867661

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

November 20, 2019

Study Start

October 18, 2019

Primary Completion

July 14, 2021

Study Completion

July 14, 2021

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)CZ(1)