NCT04904354

Brief Summary

The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Status
withdrawn

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

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
2.4 years until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

May 24, 2021

Last Update Submit

November 9, 2023

Conditions

Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Subjects who are free from device and/or procedure related Major Adverse Events (MAEs)

    Subjects free from a composite list of pre-specified procedure/device related Major Adverse Events (MAEs)

    12 months

  • Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period

    Freedom from recurrence of atrial arrhythmias

    12 months

Secondary Outcomes (1)

  • Recording of all serious adverse events/device effects

    12 months

Study Arms (2)

Paroxysmal atrial fibrillation

EXPERIMENTAL

Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation

Device: AcQBlate® Force Sensing Ablation System

Persistent atrial fibrillation

EXPERIMENTAL

Subjects schedule for a de novo ablation of persistent atrial fibrillation

Device: AcQBlate® Force Sensing Ablation System

Interventions

AcQBlate® Force Sensing Ablation SystemDEVICE

Catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets may be ablated as clinically indicated.

Paroxysmal atrial fibrillationPersistent atrial fibrillation

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 symptomatic PAF or PerAF.
  • Refractory to Antiarrhythmic Drug (AAD) treatment
  • 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 or sepsis.
  • Continuous episodes of AF Duration:
  • PAF: AF duration lasting longer than 7 days
  • Persistent AF: AF duration lasting longer than 12-months.
  • Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
  • An implantable cardiac defibrillator (ICD) or pacemaker.
  • 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) \< 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
  • Left atrial size \> 55 mm based on transthoracic echocardiogram (TTE) measurement of the anteroposterior diameter, parasternal long-axis view in M Mode and performed within the previous 180-days.
  • Evidence of heart failure (NYHA Class III or IV)
  • Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
  • Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
  • Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
  • Unstable angina or ongoing myocardial ischemia.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two distinct, non-randomized cohorts of subjects will be included; a PAF population and a PerAF population
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share