Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation

NCT04512794 | Withdrawn FDA Device

• 1 other identifier: CLP-22
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atrial Arrhythmias

Keywords

ablation; atrial arrhythmias

Outcome Measures

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

  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)

  6 Months

Other Outcomes (1)

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

  12 Months

Study Arms (1)

Non-randomized

OTHER

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

Device: AcQMap High Resolution Imaging and Mapping System

Interventions

AcQMap High Resolution Imaging and Mapping System DEVICE

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

Non-randomized

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acutus Medical: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share