Unpinning Termination Therapy for VT/VF

Not Applicable

Terminated

• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Interventions: Device: Unpinning Termination Therapy

• Registration Number: NCT03871231
• Lead Sponsor: Cardialen, Inc.

Brief Summary

This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.

Detailed Description

A prospective single-arm feasibility study involving acute testing of UPT electrotherapy in subjects with VT/VF during clinically indicated ventricular tachycardia catheter ablation procedure or indicated implantable cardioverter defibrillator implant, upgrade, or replacement or new CRT-D implant or upgrade to CRT-D.

The study involves up to two roll in subjects at each participating site followed by an UPT evaluation and refinement segment in which remaining subjects are enrolled until arrhythmia terminations from UPT delivery are reliably achieved. A prospective evaluation segment will be performed to compare UPT against SBS and ATP if sufficient subjects remain once reliable terminations from UPT are achieved.

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.

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Start: 2019-07-17
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Life expectancy of 1 year or greater
2. Male or female between 18 and 75 years of age
3. Willing and able to comply with the study protocol, provide a written informed consent
4. Indication for an endocardial VT catheter ablation for sustained, life-threatening monomorphic VT OR an indication for VF and ICD implant (de novo implant, replacement or upgrade) OR CRT-D (de novo implant, upgrade from ICD) with transvenous leads for the risk of or presence of VT and/or VF.
5. Etiology of arrhythmia, or risk of arrhythmia being ischemic dilated cardiomyopathy or non-ischemic idiopathic dilated cardiomyopathy both with LVEF ≤ 35% and meeting local standard of care
6. Medically stable at time of consent to undergo DFT testing performed under general anesthesia or conscious sedation as determined by the investigator

Exclusion Criteria

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

1. Medically unstable at time of study and unsafe to undergo DFT testing under general anesthesia or conscious sedation as determined by the investigator
2. Hemodynamic instability as determined by the investigator
3. AF or atrial flutter for ≥ 48 hours or unknown duration, and no anticoagulation for preceding 3 weeks and no preoperative transesophageal echocardiographic confirmation of the absence of RA and LA thrombus
4. AF or atrial flutter for <48 hours and no Preoperative transesophageal echocardiographic confirmation of the absence of RA and LA thrombus
5. Presence of intracardiac thrombus
6. Inability to pass catheters to heart due to vascular limitations
7. Cardiovascular anatomical defects that would complicate placement of the lead or catheter required by the protocol, including congenital heart disease and cardiac vein anomalies as determined by the investigator
8. Pregnancy confirmed by test within 7 days of procedure
9. Pacemaker dependent
10. The presence of a normally functioning left ventricular lead which is not planned for revision
11. Presence of ventricular assist device, including Intra-aortic balloon pump
12. Subjects requiring the use of I.V. inotropes and/or vasopressors for hemodynamic support in the 14 days prior to the study
13. Prior VT catheter ablation with associated serious complication, such as hemodynamic compromise despite pressor agents, stroke, cardiac perforation, AC fistula, pneumothorax, sepsis
14. Incessant VT/VF or VT/VF storm
15. LVEF < 20%
16. New York Heart Association (NYHA) Class IV heart failure
17. Planned epicardial VT ablation on the same day as the research study
18. History of hyper-coagulable state that could increase risk of thromboembolic events
19. History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support.
20. Unstable coronary artery disease as determined by the investigator
21. Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators
22. History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months
23. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis.
24. 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)
25. Morbid obesity: BMI>39 kg/m2
26. Cognitive or mental health status that would interfere with study participation and proper informed consent
27. Presence of mechanical tricuspid valve
28. Active Endocarditis
29. Ventricular arrhythmia etiology sarcoidosis
30. Valvular ventricular tachycardia
31. Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator
32. End Stage Renal Disease on hemodialysis or peritoneal dialysis, or estimated glomerular filtration rate (eGFR) <15 ml/min
33. Right atrial or right ventricular lead implanted within 12 months prior to screening
34. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unpinning Termination Therapy Arm	Unpinning Termination Therapy	Subjects will have VT/VF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia

Primary Outcome Measures

Name	Time	Method
Safety of UPT therapy	30 day post procedure	Adverse events
Parameters at which UPT terminates VT and VF	Study procedure	Voltage

Secondary Outcome Measures

Name	Time	Method
Voltage at which UPT and endocardial single biphasic shock terminate VT/VF	Study procedure	Voltage
Voltage at which UPT and ATP terminate VT	Study procedure	Voltage

Trial Locations

Locations (4)

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Norwood, South Australia, Australia

Monash Medical; 🇦🇺 Clayton, Victoria, Australia

Gold Coast; 🇦🇺 Southport, Queensland, Australia