Typical Atrial Flutter
Conditions
Brief 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.
Interventions
Percutaneous catheter ablation of the cavotricuspid isthmus
Sponsors
Acutus Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs) | 7 days | Subjects free from a composite list of pre-specified procedure/device related Serious Adverse Events (SAEs) |
| Subjects Achieving Acute Procedural Success | 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. |
Countries
Belgium, United Kingdom, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 72 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 10.05 |
| Body Mass Index | 29.41 kg/m^2 STANDARD_DEVIATION 4.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Region of Enrollment Belgium | 14 participants |
| Region of Enrollment United Kingdom | 10 participants |
| Region of Enrollment United States | 91 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 115 |
| other Total, other adverse events | 32 / 115 |
| serious Total, serious adverse events | 12 / 115 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Subjects Achieving Acute Procedural Success | 102 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Subjects Free From Procedure/Device Related Serious Adverse Events (SAEs) | 115 Participants |