Paroxysmal Atrial FibrillationAcQForce AFNCT04904354
AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation
A study testing AcQBlate® Force Sensing Ablation System in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Acutus Medical.
Trial summary
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- AcQBlate® Force Sensing Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Myocardial infarction within the previous 180-days (sub-endocardial infarct within previous 90-days).
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg) recorded within the last 30 days.
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- Presence of a left atrial appendage occlusion device.
- Previous PV stenting or evidence of PV stenosis.
- Presence of Left Atrial Thrombus
- Body Mass Index (BMI) > 42 kg/m2
- Estimated Glomerular Filtration Rate (eGFR) of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- History of blood clotting or bleeding disease.
- ANY prior history of documented cerebral infarct, or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- History of chronic obstructive pulmonary disease (COPD) requiring oral or IV steroid use in the previous 12-months.
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
- 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.
- 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).
About this study
Official title: 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.
Read the 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).
- Being tested
- AcQBlate® Force Sensing Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal atrial fibrillation | Experimental | Subjects schedule for a de novo ablation of paroxysmal atrial fibrillation Receives: Device: AcQBlate® Force Sensing Ablation System |
| Persistent atrial fibrillation | Experimental | Subjects schedule for a de novo ablation of persistent atrial fibrillation Receives: Device: AcQBlate® Force Sensing Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Freedom from recurrence of atrial arrhythmias
Measured: 12 months
Secondary outcomes (1)
Recording of all serious adverse events/device effects
Recording of all serious adverse events/device effects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: Company no longer doing clinical studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two distinct, non-randomized cohorts of subjects will be included; a PAF population and a PerAF population
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904354
- Sponsor's protocol ID
- CLP-16
- Other IDs
- CLP-16-EU
- Acronym
- AcQForce AF
- Status last verified
- Nov 2023
- First submitted
- 24 May 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcQBlate Force Sensing Ablation System US IDE Study for Atrial Fibrillation (AcQForce AF)
- ClinicalTrials.gov ID
- NCT04904354
- Acronym / sponsor ID
- AcQForce AF / CLP-16
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company no longer doing clinical studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AcQForce AF clinical study is a prospective, multi-center, non-randomized global clinical study.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two distinct, non-randomized cohorts of subjects will be included; a PAF population and a PerAF population
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal atrial fibrillation | Experimental | Device: AcQBlate® Force Sensing Ablation SystemSubjects schedule for a de novo ablation of paroxysmal atrial fibrillation |
| Persistent atrial fibrillation | Experimental | Device: AcQBlate® Force Sensing Ablation SystemSubjects schedule for a de novo ablation of persistent atrial fibrillation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (31 listed)
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis.
- Continuous episodes of AF Duration:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcQBlate® Force Sensing Ablation SystemCatheter 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. | Device | Paroxysmal atrial fibrillation, Persistent atrial fibrillation |
Primary outcome
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)
Proportion of subjects demonstrating freedom from AF/AT/AFL following a blanking period
Time frame: 12 months
Freedom from recurrence of atrial arrhythmias
1 secondary outcome
Recording of all serious adverse events/device effects
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AcQBlate® Force Sensing Ablation System in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Acutus Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects who are free from device and/or procedure related Major Adverse Events (MAEs) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.