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
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.
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 →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.
Exclusion Criteria:
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
Percutaneous catheter ablation of the cavotricuspid isthmus
Also known as: AcQBlate Force Sensing System, AcQBlate Force
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
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
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.
| Milestone | All Study Participants |
|---|---|
| Started | 115 |
| Completed | 114 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
| Participants | All Study Participants |
|---|---|
| Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs) | 115 |
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.
| Participants | All Study Participants |
|---|---|
| Subjects Achieving Acute Procedural Success | 102 |
Collected over 30 days post-procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | 0/115 (0%) | 12/115 (10.4%) | 32/115 (27.8%) |
| Event | All Study Participants |
|---|---|
| Atrioventricular block second degreeCardiac disorders | 2/115 |
| Supraventricular tachycardiaCardiac disorders | 2/115 |
| HypotensionVascular disorders | 2/115 |
| Congestive Heart FailureCardiac disorders | 1/115 |
| Chronic left ventricular failureCardiac disorders | 1/115 |
| Pericardial effusionCardiac disorders | 1/115 |
| PericarditisCardiac disorders | 1/115 |
| InfectionInfections and infestations | 1/115 |
| Deep vein thrombosisVascular disorders | 1/115 |
| Event | All Study Participants |
|---|---|
| HaematomaVascular disorders | 6/115 |
| Atrial fibrillationCardiac disorders | 4/115 |
| EcchymosisSkin and subcutaneous tissue disorders | 4/115 |
| HypertensionVascular disorders | 3/115 |
| Angina pectorisCardiac disorders | 2/115 |
| Atrial tachycardiaCardiac disorders | 1/115 |
| PericarditisCardiac disorders | 1/115 |
| Supraventricular extrasystolesCardiac disorders | 1/115 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/115 |
| Rectal haemorrhageGastrointestinal disorders | 1/115 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 72 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 68.4 ± 10.05 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 25 |
| Male | 90 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 110 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 107 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| Belgium | 14 |
| United States | 91 |
| United Kingdom | 10 |
| Body Mass Index(kg/m^2) | All Study Participants |
|---|---|
| Mean | 29.41 ± 4.59 |
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