Atrial ArrhythmiasPLASZMANCT04512794
Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation
A study testing AcQMap High Resolution Imaging and Mapping System in people with Atrial Arrhythmias, run by Acutus Medical.
Trial summary
Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation: An AcQMap Substrate Characterization Study (PLASZMA) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Arrhythmias
- What is being tested?
- AcQMap High Resolution Imaging and Mapping System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age at the time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of a complex left atrial arrhythmia including AF/AT/AFL
- 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.
Who cannot join
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, renal failure, or sepsis.
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- Any DCCV within 60-days of the index procedure where sinus rhythm was not maintained for at least 60-minutes.
- Any cardiac defibrillator (ICD) or pacemaker implanted within 8-weeks prior to the ablation procedure.
- History of previous left atrial ablation (including surgical treatment) for AF/AT/AFL.
- Structural heart disease or cardiac history including:
Show all 19Show fewer
- Left ventricular ejection fraction (LVEF) < 35% based on a 2-d transthoracic echocardiogram (TTE) within the previous 180-days prior to enrollment.
- Left atrial size > 60 mm (parasternal long-axis view) based on 2-d TTE within the previous 180-days prior to enrollment.
- Prior history of New York Heart Association (NYHA) Class IV heart failure.
- Any evidence of NYHA Class III heart failure in the previous 3-months prior to enrollment.
- Unstable angina or ongoing myocardial ischemia.
- Myocardial infarction (STEMI) within the previous 180-days (sub-endocardial infarct within previous 90-days) prior to enrollment.
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- Presence of a left atrial appendage occlusion device.
- Body Mass Index (BMI) > 40kg/m2
- History of blood clotting or bleeding disease.
- History of chronic obstructive pulmonary disease (COPD) requiring use of oxygen in the treatment regimen.
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
About this study
Official title: Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation An AcQMap Substrate Characterization Study (PLASZMA)
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.
- Conditions
- Atrial Arrhythmias
- Being tested
- AcQMap High Resolution Imaging and Mapping System
- Keywords
- ablation, atrial arrhythmias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcQMap High Resolution Imaging and Mapping SystemDevice
Evaluate the safety and effectiveness of the AcQMap System in mapping atrial arrhythmias when a specific procedure work flow is followed.
| Study group | Role | What they receive |
|---|---|---|
| Non-randomized | Other | All subjects with de novo ablation procedure for an atrial arrhythmia using the AcQMap System. Receives: Device: AcQMap High Resolution Imaging and Mapping System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512794
- Sponsor's protocol ID
- CLP-22
- Acronym
- PLASZMA
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation An AcQMap Substrate Characterization Study (PLASZMA)
- ClinicalTrials.gov ID
- NCT04512794
- Acronym / sponsor ID
- PLASZMA / CLP-22
- Conditions
- Atrial Arrhythmias
- Keywords
- ablation, atrial arrhythmias
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Non-randomized | Other | Device: AcQMap High Resolution Imaging and Mapping SystemAll subjects with de novo ablation procedure for an atrial arrhythmia using the AcQMap System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 years of age at the time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of a complex left atrial arrhythmia including AF/AT/AFL
- 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.
Key exclusion criteria (19 listed)
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, renal failure, or sepsis.
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- Any DCCV within 60-days of the index procedure where sinus rhythm was not maintained for at least 60-minutes.
- Any cardiac defibrillator (ICD) or pacemaker implanted within 8-weeks prior to the ablation procedure.
- History of previous left atrial ablation (including surgical treatment) for AF/AT/AFL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcQMap High Resolution Imaging and Mapping SystemEvaluate the safety and effectiveness of the AcQMap System in mapping atrial arrhythmias when a specific procedure work flow is followed. | Device | Non-randomized |
Primary outcome
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
Time frame: 6 Months
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
1 secondary outcome
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)
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AcQMap High Resolution Imaging and Mapping System in people with Atrial Arrhythmias, run by Acutus Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.