MultiPulse Therapy (MPT) for AF (US)

Last updated: October 7, 2022
Sponsor: Cardialen, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT05055921
CL007 (US)
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female between 18 and 80 years of age
  2. Willing and able to comply with the study protocol, provide a written informed consent
  3. Currently indicated for atrial catheter ablation due to paroxysmal or early persistentatrial fibrillation
  4. Current treatment and compliance with standard anticoagulation regimen, includinguninterrupted OAC, with acceptable coagulation status, as determined by the PrincipalInvestigator

Exclusion

Exclusion Criteria: The subject must not meet any of the following exclusion criteria:

  1. Life expectancy of 1 year or less
  2. AF due to reversible causes (e.g., hyperthyroidism, valve disease)
  3. History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
  4. Currently in AF for more than 3 months continuously
  5. Chronic, long-standing persistent, or permanent atrial fibrillation
  6. Allergy or contraindication to anticoagulation therapy
  7. Presence of intracardiac thrombus (confirmed with TEE or ICE)
  8. Existing Left Atrial Appendage closure device
  9. Severely Dilated Left Atrium >5cm
  10. LVEF<35%
  11. NYHA Class III or IV heart failure at the time of enrollment
  12. History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolicevent within the preceding 3 months.
  13. Known hyper-coagulable state that increases risk of thrombus
  14. History of myocardial infarction or coronary revascularization within the preceding 3months.
  15. History of sustained ventricular arrhythmia or cardiac arrest
  16. Presence of chronically implanted lead in the CS
  17. Presence of ventricular assist device, including intra-aortic balloon pump
  18. Documented bradycardia (<40 BPM) at the time of the study
  19. Morbid obesity: BMI>39 kg/m2
  20. Presence of any prosthetic cardiac valve
  21. History of significant tricuspid valvular disease requiring surgery
  22. Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
  23. Cognitive or mental health status that would interfere with study participation andproper informed consent
  24. Cardiovascular anatomical defects that would complicate placement of the stimulationleads required by the protocol, including congenital heart disease and cardiac veinanomalies per the Investigator's discretion
  25. Pregnancy confirmed by test within 7 days of procedure.
  26. Inability to pass catheters to heart due to vascular limitations
  27. Cardiovascular surgery or intervention within 1 month prior to enrollment or plannedfor up to 1 month after enrollment (other than the planned treatment procedure)
  28. Active endocarditis
  29. Any other medical condition which may affect the outcome of this study or safety ofthe subject as determined by the investigator
  30. History of hemodynamic compromise due to valvular heart disease
  31. Unstable CAD as determined by the investigator
  32. Severe proximal three-vessel or left main coronary artery disease withoutrevascularization as determined by the investigator
  33. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia,Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis

Study Design

Total Participants: 6
Study Start date:
February 28, 2022
Estimated Completion Date:
October 01, 2022

Study Description

A prospective non-randomized feasibility study involving acute testing of MPT in subjects with paroxysmal and persistent AF during clinically indicated atrial fibrillation catheter ablation procedure.

Subjects will be split into 2 cohorts depending on status at time of procedure.

  1. In Atrial Fibrillation at time of procedure (Clinical AF)

  2. In Normal Sinus Rhythm at time of procedure

Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.

Connect with a study center

  • Minneapolis Veterans Administration Hospital

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

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