Persistent Atrial Fibrillation
Conditions
Brief summary
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU) A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
Detailed description
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU) A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian) The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows: NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI) The above record was combined into one as both protocols are essentially identical (one is post market \[EU\] and the other pre-market \[Canada\] and one study report will be written that encompasses the data/results for both protocols.
Interventions
DEVICEAcQMap System
3D imaging and mapping system for cardiac chambers
Sponsors
Acutus Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for an ablation of persistent atrial fibrillation
Exclusion criteria
* Any duration of continuous AF lasting longer than 12 months * Previous AF ablation * Significant structural heart disease * Previous cerebral infarct * Major bleeding disorders * Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) | 24 hours | MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Events. | 12 Months | Recording of all adverse events through 12 month follow-up |
| Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. | 24 hours | Conversion to sinus rhythm post ablation |
| Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 6, 9, and 12 Months | Freedom from AF |
Countries
Canada, Czechia, Germany, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AcQMap System Use of the AcQMap System for imaging and mapping of atrial chambers during AF ablation
AcQMap System: 3D imaging and mapping system for cardiac chambers | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Procedure terminated | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | AcQMap System |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 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 | 129 Participants |
| Region of Enrollment Canada | 4 participants |
| Region of Enrollment Czechia | 11 participants |
| Region of Enrollment Germany | 46 participants |
| Region of Enrollment Italy | 6 participants |
| Region of Enrollment Netherlands | 8 participants |
| Region of Enrollment United Kingdom | 54 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 58 / 129 |
| serious Total, serious adverse events | 33 / 129 |
Outcome results
Primary
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.
Time frame: 24 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AcQMap System | Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) | Number of subjects with MAEs | 3 Participants |
| AcQMap System | Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) | Number of subjects with no MAEs | 126 Participants |
Secondary
Number of Participants Who Experienced at Least One Adverse Events.
Recording of all adverse events through 12 month follow-up
Time frame: 12 Months
Population: The safety population included all enrolled subjects who had the venous access portion of the ablation procedure initiated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | EYE DISORDERS | 1 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | ERYTHEMA OF EXTREMITIES | 1 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | BLOOD AND LYMPHATIC SYSTEM DISORDERS | 1 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | CARDIAC DISORDERS | 21 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | CONGENITAL, FAMILIAL AND GENETIC DISORDERS | 1 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | ENDOCRINE DISORDERS | 3 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | GASTROINTESTINAL DISORDERS | 8 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | GENERAL DISORDERS AND ADMIN SITE CONDITIONS | 17 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | HEPATOBILIARY DISORDERS | 2 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | INFECTIONS AND INFESTATIONS | 11 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | INJURY, POISONING AND PROCEDURAL COMPLICATIONS | 6 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | INVESTIGATIONS | 6 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | METABOLISM AND NUTRITION DISORDERS | 2 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | 2 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED | 4 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | NERVOUS SYSTEM DISORDERS | 7 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | PSYCHIATRIC DISORDERS | 1 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | RENAL AND URINARY DISORDERS | 5 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | 10 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | SKIN AND SUBCUTANEOUS TISSUE DISORDERS | 1 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | SURGICAL AND MEDICAL PROCEDURES | 3 participants |
| AcQMap System | Number of Participants Who Experienced at Least One Adverse Events. | VASCULAR DISORDERS | 16 participants |
Secondary
Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.
Freedom from AF
Time frame: 6, 9, and 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AcQMap System | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 79 Participants |
| 6 Month on AADs | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 49 Participants |
| 9 Months Off AADs | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 65 Participants |
| 9 Months on AADs | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 36 Participants |
| 12 Months Off AADs | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 84 Participants |
| 12 Months on AADs | Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | 52 Participants |
Secondary
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.
Conversion to sinus rhythm post ablation
Time frame: 24 hours
Population: Number of subjects who had an ablation procedure completed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AcQMap System | Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. | 125 Participants |