MultiPulse Therapy (MPT) for AF (US)

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

In brief

Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.

Key facts

Study ID

NCT05055921

Run by

Cardialen, Inc.

People needed

6

Starts

2022-02-28

Expected to finish

2022-10-01

Last updated by the study team

2022-10-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 and 80 years of age
• Willing and able to comply with the study protocol, provide a written informed consent
• Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation
• Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator

You may not qualify if…

• The subject must not meet any of the following exclusion criteria:
• Life expectancy of 1 year or less
• AF due to reversible causes (e.g., hyperthyroidism, valve disease)
• History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
• Currently in AF for more than 3 months continuously
• Chronic, long-standing persistent, or permanent atrial fibrillation
• Allergy or contraindication to anticoagulation therapy
• Presence of intracardiac thrombus (confirmed with TEE or ICE)
• Existing Left Atrial Appendage closure device
• Severely Dilated Left Atrium >5cm
• LVEF<35%
• NYHA Class III or IV heart failure at the time of enrollment
• History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
• Known hyper-coagulable state that increases risk of thrombus
• History of myocardial infarction or coronary revascularization within the preceding 3 months.
• History of sustained ventricular arrhythmia or cardiac arrest
• Presence of chronically implanted lead in the CS
• Presence of ventricular assist device, including intra-aortic balloon pump
• Documented bradycardia (<40 BPM) at the time of the study
• Morbid obesity: BMI>39 kg/m2
• Presence of any prosthetic cardiac valve
• History of significant tricuspid valvular disease requiring surgery
• Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
• Cognitive or mental health status that would interfere with study participation and proper informed consent
• Cardiovascular anatomical defects that would complicate placement of the stimulation leads required by the protocol, including congenital heart disease and cardiac vein anomalies per the Investigator's discretion

Where it is running

• Minneapolis Veterans Administration Hospital — Minneapolis, Minnesota, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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