Typical Atrial FlutterAcQForce AFLNCT04658940
AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
A study testing AcQBlate® Force Sensing Ablation System in people with Typical Atrial Flutter, run by Acutus Medical at 24 sites in 3 countries.
Trial summary
The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Typical Atrial Flutter
- 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
- 115 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 25 Mar 2021to 12 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
- At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
- Age 18 years or older at time of consent.
- Subjects are willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations.
Who cannot join
- In the opinion of the Investigator, any contraindication to the planned atrial ablation, including contraindications to anticoagulation therapy and any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, chronic kidney disease).
- Inability to entrain CTI dependent AFL by standard pacing at procedure.
- Any prior right atrial cavotricuspid isthmus ablation.
- Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
- Any patient scheduled or anticipating an AF ablation within the follow-up period.
- Use of amiodarone within 120 days prior to procedure.
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- Cardiac surgery within 60 days prior to enrollment.
- ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment
- Current unstable angina.
- Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment.
- Any history of a known hematologic disorder (bleeding/clotting).
- Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment.
- Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment.
- Subjects with an ejection fraction less than 30% within 90 days of enrollment.
- Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment.
- Clinically significant structural heart disease (including moderate to severe tricuspid valve regurgitation, tricuspid valve stenosis, or tricuspid valve replacement; Ebstein's anomaly, or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator.
- Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 180 days prior to enrollment.
- Body Mass Index (BMI) >42 kg/m2.
- International Normalized Ratio (INR) > 3.
- Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within the last 30-days.
- Women who are pregnant or plan to become pregnant within the course of their participation in the investigation.
- 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
24 sites in 3 countries.
24 sites in 3 countries
United States20 sites
St Alphonsus Health System
Boise, Idaho, 83704
BayCare Heath
Clearwater, Florida, 33756
Ohio State Med Ctr
Columbus, Ohio, 43201
John Muir Health
Concord, California, 94520
Hartford Hospital
Hartford, Connecticut, 06102
Penn State Health
Hershey, Pennsylvania, 17033-0850
MedStar Health Research Institute
Hyattsville, Maryland, 80784
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Lancaster General Hospital
Lancaster, Pennsylvania, 17603
Baptist Lexington Medical Center
Lexington, Kentucky, 40503
Weill Cornell
New York, New York, 10021
Celebration Hospital
Orlando, Florida, 32803
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
AZ Cardiovascular Research Center
Phoenix, Arizona, 85016
San Diego Cardiac Center Medical Group, Inc.
San Diego, California, 92123
Adventist Healthcare | White Oak Medical Center
Silver Spring, Maryland, 20904
Adventist Healthcare, Inc
Silver Spring, Maryland, 20904
Bayfront Health
St. Petersburg, Florida, 33701
ProMedica Physician Cardiology
Toledo, Ohio, 43615
United Kingdom2 sites
James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
- Conditions
- Typical Atrial Flutter
- Being tested
- AcQBlate® Force Sensing Ablation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcQBlate® Force Sensing Ablation SystemDevice
Also called AcQBlate Force Sensing System, AcQBlate Force
Percutaneous catheter ablation of the cavotricuspid isthmus
| Study group | Role | What they receive |
|---|---|---|
| Non-randomized | Experimental | All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System. 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 Free From Procedure/Device Related Serious Adverse Events (SAEs)
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
Measured: 7 days
Subjects Achieving Acute Procedural Success
Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.
Measured: 20 minutes post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start25 Mar 2021
- Primary completion12 May 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Typical Atrial FlutterStudies 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
- Masking
- None (open label)
- Enrolment
- 115 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
- NCT04658940
- Sponsor's protocol ID
- CLP-21
- Other IDs
- CLP-21-EU
- Acronym
- AcQForce AFL
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2020
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
- ClinicalTrials.gov ID
- NCT04658940
- Acronym / sponsor ID
- AcQForce AFL / CLP-21
- Conditions
- Typical Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-randomized | Experimental | Device: AcQBlate® Force Sensing Ablation SystemAll subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
- At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
- Age 18 years or older at time of consent.
- Subjects are willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations.
Key exclusion criteria (23 listed)
- In the opinion of the Investigator, any contraindication to the planned atrial ablation, including contraindications to anticoagulation therapy and any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, chronic kidney disease).
- Inability to entrain CTI dependent AFL by standard pacing at procedure.
- Any prior right atrial cavotricuspid isthmus ablation.
- Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
- Any patient scheduled or anticipating an AF ablation within the follow-up period.
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 SystemAlso: AcQBlate Force Sensing System, AcQBlate ForcePercutaneous catheter ablation of the cavotricuspid isthmus | Device | Non-randomized |
Primary outcome
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
Time frame: 7 days
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
Subjects Achieving Acute Procedural Success
Time frame: 20 minutes post ablation
Acute procedural success is defined as the demonstration of bidirectional cavotricuspid isthmus block at least 20 minutes following the last radiofrequency application at the cavotricuspid isthmus with the investigational System.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcQBlate® Force Sensing Ablation System in people with Typical Atrial Flutter, run by Acutus Medical at 24 sites in 3 countries.
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 23 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Belgium, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Free From Procedure/Device Related Serious Adverse Events (SAEs) (time frame: 7 days). 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 28 Sep 2023.