Clinical trial NCT04939584: Patient Perception of MultiPulse Therapy™ (MPT™)
Official title: A Clinical Feasibility Study to Evaluate Patient Perception of MPT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Cardialen, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective non-randomized feasibility study involving acute evaluation of the perception and acceptance of MPT as a therapy to stop episodes of AF in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure).
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Therapy acceptance as measured by a subject question administered immediately following MPT delivery
timeFrame: Immediately following MPT delivery
measure: Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
timeFrame: Immediately following MPT delivery
Secondary outcomes:
measure: Safety determined from summary report of Adverse Events
timeFrame: Through 30 days post-intervention
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: St. Andrew's Hospital
state: South Australia
Study officials:
References: