Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation (PLASZMA)

Acutus Medical

Status: Withdrawn

Conditions: Atrial Arrhythmias

Treatments: Device: AcQMap High Resolution Imaging and Mapping System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04512794

CLP-22

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 18 years of age at the time of consent
2. Clinically indicated and scheduled for a de novo catheter ablation of a complex left atrial arrhythmia including AF/AT/AFL
3. Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.

Exclusion criteria

1. In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, renal failure, or sepsis.

2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.

3. Any DCCV within 60-days of the index procedure where sinus rhythm was not maintained for at least 60-minutes.

4. Any cardiac defibrillator (ICD) or pacemaker implanted within 8-weeks prior to the ablation procedure.

5. History of previous left atrial ablation (including surgical treatment) for AF/AT/AFL.

6. Structural heart disease or cardiac history including:

   1. Left ventricular ejection fraction (LVEF) < 35% based on a 2-d transthoracic echocardiogram (TTE) within the previous 180-days prior to enrollment.
   2. Left atrial size > 60 mm (parasternal long-axis view) based on 2-d TTE within the previous 180-days prior to enrollment.
   3. Prior history of New York Heart Association (NYHA) Class IV heart failure.
   4. Any evidence of NYHA Class III heart failure in the previous 3-months prior to enrollment.
   5. Unstable angina or ongoing myocardial ischemia.
   6. Myocardial infarction (STEMI) within the previous 180-days (sub-endocardial infarct within previous 90-days) prior to enrollment.
   7. Moderate or severe valvular heart disease (stenosis or regurgitation).
   8. Presence of a left atrial appendage occlusion device.

7. Body Mass Index (BMI) > 40kg/m2

8. History of blood clotting or bleeding disease.

9. History of chronic obstructive pulmonary disease (COPD) requiring use of oxygen in the treatment regimen.

10. History of obstructive sleep apnea not currently being treated.

11. Pregnant or lactating (current or anticipated during study follow-up).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Non-randomized

Other group

Description:

All subjects with de novo ablation procedure for an atrial arrhythmia using the AcQMap System.

Treatment:

Device: AcQMap High Resolution Imaging and Mapping System