AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)

November 9, 2023 updated by: Acutus Medical

AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System in the ablation treatment of symptomatic, drug-refractory atrial fibrillation in two subject cohorts: paroxysmal atrial fibrillation, and persistent atrial fibrillation. Data will be used to support pre-market approval applications (PMAs).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female between the ages of 18 to 80 years at time of consent
  2. Clinically indicated and scheduled for a de novo catheter ablation of symptomatic PAF or PerAF.
  3. Refractory to Antiarrhythmic Drug (AAD) treatment
  4. 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.

Exclusion Criteria:

  1. In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis.

  2. Continuous episodes of AF Duration:

    1. PAF: AF duration lasting longer than 7 days
    2. Persistent AF: AF duration lasting longer than 12-months.
  3. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
  4. An implantable cardiac defibrillator (ICD) or pacemaker.
  5. Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.

  6. Structural heart disease or cardiac history as described below:

    1. Left ventricular ejection fraction (LVEF) < 40% based on transthoracic echocardiogram (TTE) within the previous 180-days.
    2. 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.
    3. Evidence of heart failure (NYHA Class III or IV)
    4. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
    5. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
    6. Coronary artery bypass graft (CABG) within the last 180-days or coronary angioplasty (PTCA) procedure within the last 90-days.
    7. Unstable angina or ongoing myocardial ischemia.
    8. Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
    9. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
    10. Moderate or severe valvular heart disease (stenosis or regurgitation).
    11. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
    12. Presence of a left atrial appendage occlusion device.
    13. Previous PV stenting or evidence of PV stenosis.
  7. Presence of Left Atrial Thrombus
  8. Body Mass Index (BMI) > 42 kg/m2
  9. Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
  10. History of blood clotting or bleeding disease.
  11. ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
  12. History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
  13. History of obstructive sleep apnea not currently being treated.
  14. Pregnant or lactating (current or anticipated during study follow-up).
  15. Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study.
  16. Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paroxysmal atrial fibrillation
Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation
Device: AcQBlate® Force Sensing Ablation System
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.
Experimental: Persistent atrial fibrillation
Subjects schedule for a de novo ablation of persistent atrial fibrillation
Device: AcQBlate® Force Sensing Ablation System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Time Frame: 12 months
Freedom from recurrence of atrial arrhythmias
12 months
Subjects who are free from device and/or procedure related Major Adverse Events (MAEs)
Time Frame: 12 months
Subjects free from a composite list of pre-specified procedure/device related Major Adverse Events (MAEs)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recording of all serious adverse events/device effects
Time Frame: 12 months
Recording of all serious adverse events/device effects
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acutus Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLP-16
  • CLP-16-EU (Other Identifier: Acutus Medical, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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