Trial Outcomes & Findings for AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter) (NCT NCT04658940)
NCT ID: NCT04658940
Last Updated: 2023-09-28
Results Overview
Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
7 days
Results posted on
2023-09-28
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 milestones
| Measure |
All Study Participants
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Study Participants
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=115 Participants
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=5 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
|
Body Mass Index
|
29.41 kg/m^2
STANDARD_DEVIATION 4.59 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysSubjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs)
Outcome measures
| Measure |
All Study Participants
n=115 Participants
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
|
Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs)
|
115 Participants
|
PRIMARY outcome
Timeframe: 20 minutes post ablationPopulation: Of the 115 subjects enrolled, 5 were attempted and had the venous access portion of the ablation procedure initiated and the AcQBlate® FORCE was inserted into the body and not used for RF ablation. Of the 110 Treated subjects, one subject was unevaluable (categorized as BDB indeterminant) therefore 109 subjects were included in primary effectiveness endpoint calculations.
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.
Outcome measures
| Measure |
All Study Participants
n=109 Participants
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
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Subjects Achieving Acute Procedural Success
|
102 Participants
|
Adverse Events
All Study Participants
Serious events: 12 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Study Participants
n=115 participants at risk
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
1.7%
2/115 • Number of events 2 • 30 days post-procedure
|
|
Cardiac disorders
Congestive Heart Failure
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Cardiac disorders
Pericardial effusion
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Cardiac disorders
Pericarditis
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.7%
2/115 • Number of events 2 • 30 days post-procedure
|
|
Infections and infestations
Infection
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Vascular disorders
Deep vein thrombosis
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Vascular disorders
Hypotension
|
1.7%
2/115 • Number of events 2 • 30 days post-procedure
|
Other adverse events
| Measure |
All Study Participants
n=115 participants at risk
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System.
AcQBlate® Force Sensing Ablation System: Percutaneous catheter ablation of the cavotricuspid isthmus
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.7%
2/115 • Number of events 2 • 30 days post-procedure
|
|
Cardiac disorders
Atrial fibrillation
|
3.5%
4/115 • Number of events 4 • 30 days post-procedure
|
|
Cardiac disorders
Atrial tachycardia
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Cardiac disorders
Pericarditis
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
General disorders
Chest discomfort
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Immune system disorders
Hypersensitivity
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Infections and infestations
COVID-19
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Infections and infestations
Groin abscess
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.5%
4/115 • Number of events 4 • 30 days post-procedure
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.87%
1/115 • Number of events 1 • 30 days post-procedure
|
|
Vascular disorders
Haematoma
|
5.2%
6/115 • Number of events 6 • 30 days post-procedure
|
|
Vascular disorders
Hypertension
|
2.6%
3/115 • Number of events 3 • 30 days post-procedure
|
Additional Information
Karen Stephens, Director Clinical Affairs
Acutus Medical
Phone: 442-232-6080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place