CClinicalTrials.gg
CompletedNCT04658940AcQForce AFLUpdated Sep 28, 2023Results posted

AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)

An interventional study of AcQBlate® Force Sensing Ablation System in Typical Atrial Flutter, sponsored by Acutus Medical. Completed at 24 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Acutus Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Typical Atrial Flutter

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03

In context

Atrial Flutter

213 studies on the registry are indexed under Atrial Flutter; 50 are open to participants now.

This study's enrollment of 115 is below the median of 134 across 145 interventional studies indexed under Atrial Flutter.

Browse Atrial Flutter studies →

Lead sponsor

Acutus Medical is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects are clinically indicated for de novo catheter ablation of typical atrial flutter.
  2. At least one (1) documented episode of typical atrial flutter within 180 days (6 months) prior to enrollment, documented by 12-lead ECG.
  3. Age 18 years or older at time of consent.
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Inability to entrain CTI dependent AFL by standard pacing at procedure.
  3. Any prior right atrial cavotricuspid isthmus ablation.
  4. Any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment.
  5. Any patient scheduled or anticipating an AF ablation within the follow-up period.
  6. Use of amiodarone within 120 days prior to procedure.
  7. Cardiac surgery within 60 days prior to enrollment.
  8. ST-elevation myocardial infarction (STEMI) within 60 days prior to enrollment
  9. Current unstable angina.
  10. Documented atrial or ventricular tumors, clots, thrombus, within 30-days prior to enrollment.
  11. Any history of a known hematologic disorder (bleeding/clotting).
  12. Implantation of permanent leads of an implantable device in or through the right atrium within 90-days prior to enrollment.
  13. Subjects with New York Heart Association (NYHA) Class IV heart failure within 6-months prior to enrollment.
  14. Subjects with an ejection fraction less than 30% within 90 days of enrollment.
  15. Percutaneous Transluminal Coronary Angioplasty (PTCA) within 30-days of enrollment.
  16. 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.
  17. Any cerebral ischemic/infarct event (excluding transient ischemic attacks) within 180 days prior to enrollment.
  18. Body Mass Index (BMI) >42 kg/m2.
  19. International Normalized Ratio (INR) > 3.
  20. Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg) within the last 30-days.
  21. Women who are pregnant or plan to become pregnant within the course of their participation in the investigation.
  22. 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.
  23. 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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    Non-randomized

    All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.

    Device: AcQBlate® Force Sensing Ablation System

Interventions

  • DeviceAcQBlate® Force Sensing Ablation System

    Percutaneous catheter ablation of the cavotricuspid isthmus

    Also known as: AcQBlate Force Sensing System, AcQBlate Force

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 7 days

  2. 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.

    Time frame: 20 minutes post ablation

07

Results

Posted Sep 28, 2023

Participant flow

Subject classification: Screen Failure: exclusion criteria identified. Enrolled: study eligible by meeting all the inclusion and none of the exclusion criteria, up to the point of the procedure (defined as the AcQBlate® FORCE inserted into the body). Attempted: the AcQBlate® FORCE was inserted into the body and not used for RF ablation. Treated: the AcQBlate® FORCE was inserted into the body and used for RF ablation.

Participant flow — Overall Study
MilestoneAll Study Participants
Started115
Completed114
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimarySubjects 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)

Time frame:
7 days
Reported as:
Count of participants · Participants
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
ParticipantsAll Study Participants
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)115
PrimarySubjects 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.

Time frame:
20 minutes post ablation
Reported as:
Count of participants · Participants
Subjects Achieving Acute Procedural Success
ParticipantsAll Study Participants
Subjects Achieving Acute Procedural Success102

Adverse events

Collected over 30 days post-procedure. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Study Participants0/115 (0%)12/115 (10.4%)32/115 (27.8%)
Most frequent serious events
Most frequent serious events
EventAll Study Participants
Atrioventricular block second degreeCardiac disorders2/115
Supraventricular tachycardiaCardiac disorders2/115
HypotensionVascular disorders2/115
Congestive Heart FailureCardiac disorders1/115
Chronic left ventricular failureCardiac disorders1/115
Pericardial effusionCardiac disorders1/115
PericarditisCardiac disorders1/115
InfectionInfections and infestations1/115
Deep vein thrombosisVascular disorders1/115
Most frequent other events
Showing 10 of 18
Most frequent other events
EventAll Study Participants
HaematomaVascular disorders6/115
Atrial fibrillationCardiac disorders4/115
EcchymosisSkin and subcutaneous tissue disorders4/115
HypertensionVascular disorders3/115
Angina pectorisCardiac disorders2/115
Atrial tachycardiaCardiac disorders1/115
PericarditisCardiac disorders1/115
Supraventricular extrasystolesCardiac disorders1/115
Gastrointestinal haemorrhageGastrointestinal disorders1/115
Rectal haemorrhageGastrointestinal disorders1/115

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years0
Between 18 and 65 years43
>=65 years72
Age, Continuous
Age, Continuous(years)All Study Participants
Mean68.4 ± 10.05
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female25
Male90
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Study Participants
Hispanic or Latino5
Not Hispanic or Latino110
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Study Participants
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American7
White107
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Study Participants
Belgium14
United States91
United Kingdom10
Body Mass Index
Body Mass Index(kg/m^2)All Study Participants
Mean29.41 ± 4.59
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Study locations

24 sites
  • AZ Cardiovascular Research Center
    Phoenix, Arizona 85016, United States
  • Arrhythmia Research Group
    Jonesboro, Arkansas 72401, United States
  • John Muir Health
    Concord, California 94520, United States
  • San Diego Cardiac Center Medical Group, Inc.
    San Diego, California 92123, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • BayCare Heath
    Clearwater, Florida 33756, United States
  • Celebration Hospital
    Orlando, Florida 32803, United States
  • Bayfront Health
    Saint Petersburg, Florida 33701, United States
  • St Alphonsus Health System
    Boise, Idaho 83704, United States
  • Kansas City Heart Rhythm Institute
    Overland Park, Kansas 66211, United States
  • Baptist Lexington Medical Center
    Lexington, Kentucky 40503, United States
  • MedStar Health Research Institute
    Hyattsville, Maryland 80784, United States
  • Adventist Healthcare | White Oak Medical Center
    Silver Spring, Maryland 20904, United States
  • Adventist Healthcare, Inc
    Silver Spring, Maryland 20904, United States
  • Weill Cornell
    New York, New York 10021, United States
  • Ohio State Med Ctr
    Columbus, Ohio 43201, United States
  • ProMedica Physician Cardiology
    Toledo, Ohio 43615, United States
  • Penn State Health
    Hershey, Pennsylvania 17033-0850, United States
  • Lancaster General Hospital
    Lancaster, Pennsylvania 17603, United States
  • Presbyterian Medical Center
    Philadelphia, Pennsylvania 19104, United States
  • ZNA Middelheim
    Antwerpen, 2020, Belgium
  • Jessa Ziekenhuis
    Hasselt, 3500, Belgium
  • James Cook University Hospital
    Middlesbrough, TS4 3BW, United Kingdom
  • Freeman Hospital
    Newcastle Upon Tyne, NE7 7DN, United Kingdom
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References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04658940
Lead sponsor
Acutus Medical
Responsible party
Sponsor
First posted
Dec 9, 2020
Start date
Mar 25, 2021
Primary completion
May 12, 2022
Completion
Jun 12, 2022
Results posted
Sep 28, 2023
Last update
Sep 28, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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