Clinical trial NCT04512794: Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation
Official title: Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation An AcQMap Substrate Characterization Study (PLASZMA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Arrhythmias
Keywords: ablation
atrial arrhythmias
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2020-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subject population will consist of men and women 18 years of age or older presenting for a de novo ablation of a symptomatic, complex atrial arrhythmia including atrial fibrillation/atrial tachycardia/atrial flutter
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
timeFrame: 6 Months
Secondary outcomes:
measure: 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)
timeFrame: 6 Months
Other outcomes:
measure: Number of subjects who are free from AF/AT/AFL (following a 90-day blanking period)
timeFrame: 12 Months
Locations:
Study officials:
References: