Supraventricular Tachycardia
Conditions
Brief summary
Use of dipole density mapping to identify activation in complex supraventricular tachycardias.
Detailed description
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows: NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, & Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI) All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
Interventions
DEVICEDipole Density Mapping with AcQMap followed by ablation
Sponsors
Acutus Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Be aged 18-75 years 2. Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs. 3. Be able and willing to give informed consent
Exclusion criteria
1. Have any of the following: * implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped * permanent pacemaker or ICD leads in the chamber being mapped * hypercoagulopathy or an inability to tolerate anticoagulation during the procedure * Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY) 2. MI within the prior two (2) months 3. Cardiac surgery within the prior three (3) months 4. Intracardiac thrombus 5. Clinically significant tricuspid and/or mitral valve regurgitation or stenosis 6. Cerebral ischemic event (including TIA) in the prior six (6) months 7. Pregnant or nursing 8. Currently enrolled in another clinical investigation 9. Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY) 10. Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY) 11. Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY) 12. Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY) NOTE: The additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | 7 days | Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition. |
| The Number of Patients for Which Activation Maps Can be Created | 1 day | The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps. |
Countries
Belgium, Canada, Chile, Czechia, Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dipole Density Mapping Subjects scheduled for an ablation of a supraventricular tachycardia due to the arrhythmia being recurrent using the AcQMap High Resolution Imaging and Mapping System (AcQMap System) in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardias (SVTs).
Follow-up is 7-10 days for non-AF patients (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each patient. | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Not consented for long-term follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Dipole Density Mapping |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 85 Participants |
| Region of Enrollment Belgium | 2 participants |
| Region of Enrollment Canada | 10 participants |
| Region of Enrollment Chile | 3 participants |
| Region of Enrollment Czechia | 29 participants |
| Region of Enrollment Germany | 12 participants |
| Region of Enrollment United Kingdom | 29 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 85 |
| other Total, other adverse events | 30 / 85 |
| serious Total, serious adverse events | 10 / 85 |
Outcome results
Primary
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.
Time frame: 7 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | AF Subjects | 71 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Non-AF Subjects | 14 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Freedom a device related SAE @ 7dys | 85 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Freedom from a procedure-related SAE @ 7-dys | 83 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Freedom from an related AcQGuide SAE @ 7-dys | 71 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Freedom from a device related AE @ 7-days | 85 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Freedom from a procedure-related AE @ 7-days post | 64 Participants |
| Treated Subjects | Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events | Freedom from an AcQGuide Sheath related AE @ 7-day | 71 Participants |
Primary
The Number of Patients for Which Activation Maps Can be Created
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Time frame: 1 day
Population: The study population consists of men and women between the ages of 18 - 75 years of age scheduled for an endocardial ablation for a supraventricular tachycardia (SVT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated Subjects | The Number of Patients for Which Activation Maps Can be Created | Pre-procedure activation maps | 83 participants |
| Treated Subjects | The Number of Patients for Which Activation Maps Can be Created | Post-procedure activation maps | 71 participants |