The objective of the clinical study is to evaluate the incidence of device- and procedure-related safety, efficacy, and efficiency (6-and 12-month outcomes) when using the AcQMap as an imaging and mapping system for ablation of persistent atrial…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary measurable objective is an analysis of the proportion of subjects
who are free from device/procedure related Major Adverse Events (MAEs) that
occur within the first 24 hours post-procedure. MAEs include any of the
following:
- Death
- Cardiac perforation/tamponade
- Cerebral infarct, transient ischemic attack (TIA), or systemic embolism
- Major bleeding
- Mitral or tricuspid valvular damage
- Other serious adverse device effects (SADEs) adjudicated by an independent
Clinical Events Committee (CEC) as *probably related* to the AcQMap System
Secondary outcome
Secondary measurable objectives include the following:
Safety Outcome Measure
- Recording and analysis of all identified adverse events (AEs) and adverse
device effects (ADEs) through 12 months post-procedure. Events will be
adjudicated by an independent Clinical Events Committee (CEC) for severity and
relationship to the AcQMap.
Procedure Outcome Measure
- Analysis of the proportion of subjects with acute procedural (ablation)
success
defined as: Conversion to sinus rhythm (with or without DCCV) within 12 hours
of the procedure OR procedural conversion to atrial flutter, atrial tachycardia
or other organized supraventricular rhythm
- Procedure fluoroscopy time
- Ablation time to complete PVI
- Ablation time for non-PVI ablation
- Ablation time for right atrial ablation
- Number of DCCV completed during the procedure
Background summary
Although much has been learned about the mechanisms of AF, they are not
completely understood. Because of this, in the great majority of AF patients,
it is not yet possible to precisely tailor an ablation strategy to a particular
AF mechanism.
Three-dimensional (3D) electroanatomical contact and noncontact mapping systems
have been reported to facilitate ablation of AF by identifying anatomical
structures and highlighting the location of ablated sites. This can guide the
initial ablation and help identify existing gaps in an incomplete lesion set.
Additionally, electromagnetic navigation systems have been shown to
substantially reduce the fluoroscopy time required for AF ablation.
The AcQMap* High Resolution Imaging and Mapping System (AcQMap System) has been
designed to provide information on cardiac dipole densities as a function of
time and project that information on an image of a cardiac chamber. In this
study, the AcQMap System will collect data from the AcQMap 3D Imaging and
Mapping Catheter (AcQMap Catheter) to create anatomical reconstructions of the
chamber(s) being mapped and to create Dipole Density maps on those
reconstructions. These maps will then be used to identify mechanisms of atrial
fibrillation, which can be targeted for ablation.
Study objective
The objective of the clinical study is to evaluate the incidence of device- and
procedure-related safety, efficacy, and efficiency (6-and 12-month outcomes)
when using the AcQMap as an imaging and mapping system for ablation of
persistent atrial fibrillation (AF).
Study design
The clinical study is 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 during an ablation of persistent atrial
fibrillation.
Study burden and risks
Pre-clinical research and current clinical studies have demonstrated that the
system is safe for human use. All potential risks have been evaluated and
mitigation strategies have been implemented to reduce potential risks to
acceptable levels. Acutus Medical believes that the potential benefits of the
system outweigh the potential risks.
The AcQMap System provides automatic and instantaneous 3D displays of the
chamber surface and Dipole Density maps on that surface, which may be able to
identify mechanisms of AF that cannot be identified using standard tools. This
has the potential of improving ablation efficiency and shortening procedure
time. This may also prove to be more effective at verifying an appropriate
endpoint to the ablation. This may provide the Investigator with an intuitive
tool to rapidly identify and guide treatment of clinically-relevant targets for
ablation. This may also positively impact long-term outcomes of maintaining
sinus rhythm in the future. There is; however, no guarantee that this will
occur. Through the subject*s participation in this study, the information
gathered will add to the understanding of Dipole Density Mapping. This
knowledge may advance medical science and may benefit future subjects, as well
as society at large.
Acutus Medical, Inc. 2210 Faraday Ave Suite 100
Carlsbad 92008
US
Acutus Medical, Inc. 2210 Faraday Ave Suite 100
Carlsbad 92008
US
Listed location countries
Age
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02825992 |
| CCMO | NL59276.068.16 |