NCT04512794

Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation

Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation An AcQMap Substrate Characterization Study (PLASZMA)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Acutus Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation: An AcQMap Substrate Characterization Study (PLASZMA)

Detailed description

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.

Conditions

• Atrial Arrhythmias

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2020-08-14
• Last updated: 2022-03-22

Regulatory

• FDA-regulated device study