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WithdrawnNCT04512794PLASZMAUpdated Mar 22, 2022

Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation

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 Withdrawn.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

Why this study was withdrawn
Company decision
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Atrial Arrhythmias

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Keywords

  • ablation
  • atrial arrhythmias
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Non-randomized

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

    Device: AcQMap High Resolution Imaging and Mapping System

Interventions

  • DeviceAcQMap 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04512794
Lead sponsor
Acutus Medical
Responsible party
Sponsor
First posted
Aug 14, 2020
Start date
Sep 1, 2022 (estimated)
Primary completion
Sep 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Mar 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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