Trial Outcomes & Findings for Dipole Density Mapping in Supraventricular Tachycardia (NCT NCT02469623)
NCT ID: NCT02469623
Last Updated: 2019-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
7 days
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
Treated Subjects
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).
|
|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Treated Subjects
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).
|
|---|---|
|
Overall Study
Not consented for long-term follow-up
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Dipole Density Mapping in Supraventricular Tachycardia
Baseline characteristics by cohort
| Measure |
Dipole Density Mapping
n=85 Participants
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.
|
|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
85 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
Canada
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
29 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysSites 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.
Outcome measures
| Measure |
Treated Subjects
n=85 Participants
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).
|
|---|---|
|
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
AF Subjects
|
71 Participants
|
|
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Non-AF Subjects
|
14 Participants
|
|
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Freedom a device related SAE @ 7dys
|
85 Participants
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 1 dayPopulation: 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)
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Outcome measures
| Measure |
Treated Subjects
n=85 Participants
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).
|
|---|---|
|
The Number of Patients for Which Activation Maps Can be Created
Pre-procedure activation maps
|
83 participants
|
|
The Number of Patients for Which Activation Maps Can be Created
Post-procedure activation maps
|
71 participants
|
Adverse Events
Treated Subjects
Serious events: 10 serious events
Other events: 30 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treated Subjects
n=85 participants at risk
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).
|
|---|---|
|
Surgical and medical procedures
Access site Injury
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Surgical and medical procedures
Ablation re-do requiring hospitalization
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Surgical and medical procedures
Valve Dysfunction
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Renal and urinary disorders
Acute renal Insufficiency
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinomamammae sin
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Shortness of Breath
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Arrhythmia
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Tumor
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Death
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Endocrine disorders
Abnormal Thyroid Function
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Infections and infestations
Chest Infection
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Atrial Flutter
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
Other adverse events
| Measure |
Treated Subjects
n=85 participants at risk
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).
|
|---|---|
|
Cardiac disorders
Abnormal ECG
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Infections and infestations
Abnormal lab value/infection
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Surgical and medical procedures
Access site injury
|
16.5%
14/85 • Number of events 14 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Surgical and medical procedures
Air embolism/ST change
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Musculoskeletal and connective tissue disorders
Arm Fracture
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Chest Pain
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Dizziness and Syncope
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Exertional Dyspnea
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Surgical and medical procedures
Groin Hematoma
|
4.7%
4/85 • Number of events 4 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Blood and lymphatic system disorders
Hemorrhoid Bleeding
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Hypertension
|
2.4%
2/85 • Number of events 2 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Infections and infestations
Infection
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
General disorders
Lower Extremity Swelling
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Pericarditis
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Pleuritic Chest pain
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Shortness of breath
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
General disorders
Stumble/Fall
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
General disorders
Swollen Legs
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Symptomatic Palpitations
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Cardiac disorders
Syncope
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
Endocrine disorders
Tonsilitis
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
|
General disorders
Vertigo
|
1.2%
1/85 • Number of events 1 • Follow-up is 7-10 days for non-AF subjects (except in Germany where all subjects were followed for 1 year) and 1 year for AF patients following the procedure for each subject.
|
Additional Information
Steve McQuillan, Sr. Vice President Regulatory, Clinical, & Quality Assurance
Acutus Medical, Inc.
Phone: 442232608-
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place