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Unpinning Termination Therapy for VT/VF

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ClinicalTrials.gov Identifier: NCT03871231
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Genae
Five Corners
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ventricular Fibrillation Device: Unpinning Termination Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized, non-blinded, prospective, single-arm, acute, early-feasibility study
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: An International Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT/VF
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
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
Device: 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.
Other Names:
  • Multi-pulse therapy
  • Multi-stage therapy
  • Multi-stage electrotherapy




Primary Outcome Measures :
  1. Safety of UPT therapy [ Time Frame: Study procedure and 30 day post procedure ]
    Adverse events

  2. Safety of UPT therapy [ Time Frame: 30 day post procedure ]
    Adverse events

  3. Parameters at which UPT terminates VT and VF [ Time Frame: Study procedure ]
    Voltage


Secondary Outcome Measures :
  1. Voltage at which UPT and endocardial single biphasic shock terminate VT/VF [ Time Frame: Study procedure ]
    Voltage

  2. Voltage at which UPT and ATP terminate VT [ Time Frame: Study procedure ]
    Voltage



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871231


Contacts
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Contact: Dave Munneke, MS 6128049516 DMunneke@cardialen.com
Contact: Thomas Rasmussen, BA 7196596363 trasmussen@cardialen.com

Locations
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Australia, Queensland
The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Contact: Maricel Roxas, RN    +61 7 3139 5906    maricel.roxas@health.qld.gov.au   
Contact: Megan Mearns, RN    +61 7 3139 4711    megan.mearns@health.qld.gov.au   
Sponsors and Collaborators
Cardialen, Inc.
Genae
Five Corners
Investigators
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Principal Investigator: Harris Haqqani, MD The Prince Charles Hospital

Publications:

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Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT03871231     History of Changes
Other Study ID Numbers: CL006
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Cardialen, Inc.:
Termination
Unpinning
Therapy
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes