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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03871231




Registration number
NCT03871231
Ethics application status
Date submitted
5/03/2019
Date registered
12/03/2019

Titles & IDs
Public title
Unpinning Termination Therapy for VT/VF
Scientific title
An International Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT/VF
Secondary ID [1] 0 0
CL006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia 0 0
Ventricular Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Unpinning Termination Therapy

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


Treatment: Devices: Unpinning Termination Therapy
The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen Unpinning Therapy (UPT) therapy. The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of UPT therapy
Timepoint [1] 0 0
Study procedure and 30 day post procedure
Primary outcome [2] 0 0
Safety of UPT therapy
Timepoint [2] 0 0
30 day post procedure
Primary outcome [3] 0 0
Parameters at which UPT terminates VT and VF
Timepoint [3] 0 0
Study procedure
Secondary outcome [1] 0 0
Voltage at which UPT and endocardial single biphasic shock terminate VT/VF
Timepoint [1] 0 0
Study procedure
Secondary outcome [2] 0 0
Voltage at which UPT and ATP terminate VT
Timepoint [2] 0 0
Study procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2021
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Gold Coast - Southport
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Norwood
Recruitment hospital [4] 0 0
Monash Medical - Clayton
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5067 - Norwood
Recruitment postcode(s) [4] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cardialen, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Genae
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Five Corners
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Harris Haqqani, MD
Address 0 0
The Prince Charles Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03871231