An interventional study of AcQMap High Resolution Imaging and Mapping System in Atrial Arrhythmias, sponsored by Acutus Medical. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Acutus Medical · Not applicable, Interventional, and Diagnostic
Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation: An AcQMap Substrate Characterization Study (PLASZMA)
The AcQMap Imaging and Mapping System® is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with specified Patient Electrodes, the AcQMap System is intended to display the position of the AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
Browse Arrhythmias, Cardiac studies →Acutus Medical is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Structural heart disease or cardiac history including:
All subjects with de novo ablation procedure for an atrial arrhythmia using the AcQMap System.
Device: AcQMap High Resolution Imaging and Mapping System
Evaluate the safety and effectiveness of the AcQMap System in mapping atrial arrhythmias when a specific procedure work flow is followed.
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
MAEs inlcude: death, myocardial infarction, cardiac perforation/tamponade, cerebral infarct, or systemic embolism, Major bleeding requiring transfusion of blood products, Mitral or tricuspid valve damage, Symptomatic pulmonary vein (PV) stenosis, Asymptomatic PV stenosis ≥ 70%, Permanent phrenic nerve injury, Access site complications requiring pharmacological or surgical intervention, Atrio-esophageal fistula, Pericarditis, Heart block requiring a permanent pacemaker, Vagal nerve injury leading to gastroparesis, Other serious adverse device effects (SADEs), including transient ischemic attack (TIAs), adjudicated as "probably or definitely related" to the AcQMap System
Time frame: 6 Months
Number of Participants Who Experienced at Least One procedure and device related Serious Adverse Events.serious adverse device effects (SADEs), and all unanticipated device effects (UADEs)
Recording of all SAEs/SADEs/UADEs through 6-months-procedure
Time frame: 6 Months
Number of subjects who are free from AF/AT/AFL (following a 90-day blanking period)
Time to first event of any atrial arrhythmia from day 91 through 12 months.
Time frame: 12 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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