Atrial ArrhythmiasNCT04429464
AcQBlate Force Confirmatory Study for Atrial Arrhythmias
A study testing AcQBlate Force Sensing Ablation Catheter in people with Atrial Arrhythmias, run by Acutus Medical at 1 site in Czechia.
Trial summary
AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Arrhythmias
- What is being tested?
- AcQBlate Force Sensing Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2020to 15 Nov 2020
- 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 or repeat catheter ablation of PAF or PerAF
- Willing and able to provide written informed consent to 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 AF > 12-months (long-standing persistent AF)
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
- Structural heart disease or cardiac history as described below:
- Left ventricular ejection fraction (LVEF) < 35% based on transthoracic echocardiogram (TTE) within the previous 180-days.
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- Left atrial size > 55 mm based on TTE 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) or coronary angioplasty (PTCA) procedure within the last 90-days.
- Unstable angina or ongoing myocardial ischemia.
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg recorded within the last 30-days.
- Moderate or severe tricuspid stenosis or regurgitation.
- Moderate or severe mitral 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
- Body Mass Index (BMI) >40 kg/m2
- History of blood clotting or bleeding disease.
- Any prior history of documented cerebral infarct or systemic embolism (excluding post- operative deep vein thrombosis (DVT)).
- Pregnant or lactating (current or anticipated during study follow up).
- Current enrollment in any other study protocol where testing or results from the 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
Read the detailed description
Acutus Medical's AcQBlate Force Ablation Catheter when used in combination with the Qubic Force Sensing Module (AcQBlate Force System), is indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent atrial arrhythmias.
- Conditions
- Atrial Arrhythmias
- Being tested
- AcQBlate Force Sensing Ablation Catheter
- Keywords
- ablation, atrial arrhythmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcQBlate Force Sensing Ablation CatheterDevice
Confirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias
| Study group | Role | What they receive |
|---|---|---|
| Non-randomized | Experimental | All subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia. Receives: Device: AcQBlate Force Sensing Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects that demonstrate electrical isolation of the intended ablation
The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.
Measured: At the end of their ablation procedure
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 30-days.
Measured: Through 30-days post procedure
Secondary outcomes (2)
Subjects with freedom from an atrial arrhythmia
The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 30-days post index procedure.
Measured: 30-days post index procedure
Analysis of all identified SAEs, SADEs, and UADEs.
The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs) through 30-days post-procedure.
Measured: Through 30-days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Oct 2020 (estimated)
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Nov 2020 (estimated)
Why it stopped: Due to restrictions related to COVID the sponsor has decided not to move forward with this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiasStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429464
- Sponsor's protocol ID
- CLP-14
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
- ClinicalTrials.gov ID
- NCT04429464
- Acronym / sponsor ID
- CLP-14
- Conditions
- Atrial Arrhythmias
- Keywords
- ablation, atrial arrhythmia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to restrictions related to COVID the sponsor has decided not to move forward with this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Nov 2020 (estimated)
- First posted
- 12 Jun 2020 (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.
AcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
Detailed description
Acutus Medical's AcQBlate Force Ablation Catheter when used in combination with the Qubic Force Sensing Module (AcQBlate Force System), is indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent atrial arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo or repeat left-sided atrial ablation for symptomatic paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PerAF).
| Arm | Type | Receives |
|---|---|---|
| Non-randomized | Experimental | Device: AcQBlate Force Sensing Ablation CatheterAll subjects will be treated using the Acutus Medical's AcQBlate Force Sensing Ablation Catheter in combination with the Qubic Force Sensing Module (AcQBlate Force Sensing System) to treat their arrhythmia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between the ages of 18 to 80 years at time of consent.
- Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or PerAF
- Willing and able to provide written informed consent to 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 (24 listed)
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis
- Continuous AF > 12-months (long-standing persistent AF)
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
- Structural heart disease or cardiac history as described below:
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 CatheterConfirmation that the AcQBlate Force System is safe and effective for the treatment of atrial arrhythmias | Device | Non-randomized |
Primary outcome
Subjects that demonstrate electrical isolation of the intended ablation
Time frame: At the end of their ablation procedure
The Primary Endpoint for Performance is an analysis of the proportion of subjects that demonstrate electrical isolation (block) of the intended ablation targets.
Proportion of subjects who are free from device/procedure related Major Adverse Events
Time frame: Through 30-days post procedure
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 30-days.
2 secondary outcomes
Subjects with freedom from an atrial arrhythmia
Time frame: 30-days post index procedure
Analysis of all identified SAEs, SADEs, and UADEs.
Time frame: Through 30-days post procedure
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 20 Oct 2021.
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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.
Petr Neuzil, MD principal investigator
Na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcQBlate Force Sensing Ablation Catheter in people with Atrial Arrhythmias, run by Acutus Medical at 1 site in Czechia.
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 3 inclusion and 24 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 that demonstrate electrical isolation of the intended ablation (time frame: At the end of their ablation procedure). 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 20 Oct 2021.