Status:
WITHDRAWN
Pulmonary Vein Isolation Plus Left Atrial Slow Zone Mapping and Ablation
Lead Sponsor:
Acutus Medical
Conditions:
Atrial Arrhythmias
Eligibility:
All Genders
18-80 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04512794
Start Date
September 1 2022
End Date
December 1 2023
Last Update
March 22 2022
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