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

Primary Purpose

Atrial Arrhythmias

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

AcQMap High Resolution Imaging and Mapping System

About this trial

This is an interventional diagnostic trial for Atrial Arrhythmias focused on measuring ablation, atrial arrhythmias

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
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.
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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Non-randomized

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04512794

First Posted

August 11, 2020

Last Updated

March 8, 2022

Sponsor

Acutus Medical

1. Study Identification

Unique Protocol Identification Number

NCT04512794

Brief Title

Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation

Acronym

PLASZMA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Company decision

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acutus Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Arrhythmias

Keywords

ablation, atrial arrhythmias

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Non-randomized

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

AcQMap High Resolution Imaging and Mapping System

Intervention Description

Evaluate the safety and effectiveness of the AcQMap System in mapping atrial arrhythmias when a specific procedure work flow is followed.

Primary Outcome Measure Information:

Title

Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)

Description

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

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)

Description

Recording of all SAEs/SADEs/UADEs through 6-months-procedure

Time Frame

6 Months

Other Pre-specified Outcome Measures:

Title

Number of subjects who are free from AF/AT/AFL (following a 90-day blanking period)

Description

Time to first event of any atrial arrhythmia from day 91 through 12 months.

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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: 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).

12. IPD Sharing Statement

Plan to Share IPD

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Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation

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