Patient Perception of MultiPulse Therapy™ (MPT™)

Atrial Fibrillation Clinical Trial

Official title:

A Clinical Feasibility Study to Evaluate Patient Perception of MPT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04939584
• Other study ID #: CL008
• Status: Terminated
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Cardialen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.

Description:

A prospective non-randomized feasibility study involving acute testing of MPT in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure). The primary outcome of the study is the subject response to questions regarding perception and acceptability following MPT delivery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. History of Atrial Fibrillation in past 12 months

4. Indicated to undergo an acute electrophysiology procedure allowing for conscious participation in the clinical study

5. Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator

Study stage dependent: Stage 1:

6a. History of DC-Cardioversion in past 12 months: With or Without

7b. AFEQT Score: <=89

Study stage dependent: Stage 2 (based on results from study stage 1):

6a: History of DC-Cardioversion in past 12 months: Potential emphasis on patients with history of DCCV

7b. AFEQT Score: Potential emphasis on patients with AFEQT <= 58

Exclusion Criteria:

1. Life expectancy of 1 year or less

2. AF due to reversible causes (e.g., hyperthyroidism, valve disease)

3. Hx of fibromyalgia or any other evidence of wide-spread pain

4. Any current pain condition that could be confused with pain or discomfort associated with MPT

5. >1 current well-defined pain condition (e.g., migraine, joint OA, painful diabetic neuropathy)

6. Use of any opioid analgesic (including tramadol) within 3 months of screening

7. Spielberger's STAI-AD-Trait > 75

8. AFEQT: Section 1: "I was never aware of having atrial fibrillation" is checked

9. Allergy or contraindication to anticoagulation therapy

10. Presence of intracardiac thrombus (confirmed with cardiac imaging)

11. Existing Left Atrial Appendage closure device

12. LVEF<20%

13. NYHA Class IV heart failure at the time of enrollment

14. History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.

15. Known hyper-coagulable state that increases risk of thrombus

16. History of myocardial infarction or coronary revascularization within the preceding 3 months.

17. History of sustained ventricular arrhythmia or cardiac arrest

18. Presence of chronically implanted lead in the CS

19. Presence of ventricular assist device, including intra-aortic balloon pump

20. Documented bradycardia (<40 BPM) at the time of the study

21. Morbid obesity: BMI>39 kg/m2

22. Presence of any prosthetic cardiac valve

23. History of significant tricuspid valvular disease requiring surgery

24. Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)

25. Cognitive or mental health status that would interfere with study participation and proper informed consent

26. 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

27. Pregnancy confirmed by test within 7 days of procedure.

28. Inability to pass catheters to heart due to vascular limitations

29. Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure)

30. Active endocarditis

31. History of hemodynamic compromise due to valvular heart disease

32. Unstable CAD as determined by the investigator

33. Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator

34. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis

35. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• MultiPulse Therapy
Electrical Stimulation

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	St. Andrew's Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Cardialen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy acceptance as measured by a subject question administered immediately following MPT delivery	Question: "Now I want you to think about your experiences with Atrial Fibrillation. Think about how it makes you feel, your daily life while in atrial fibrillation and your experience with in-clinic treatments for atrial fibrillation. If you could use the stimulation you just felt at home and under your control, would you use this stimulation therapy to stop your atrial fibrillation? Please answer yes or no."	Immediately following MPT delivery
Primary	Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery	Question: "Please rate any pain you experienced at the time of the stimulus, was it: No pain, mild pain, moderate pain, severe pain, the worst possible pain imaginable."?	Immediately following MPT delivery
Secondary	Safety determined from summary report of Adverse Events	Adverse Event frequency by Adverse Event type	Through 30 days post-intervention