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Unpinning Termination Therapy for VT (US)

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ClinicalTrials.gov Identifier: NCT03093051
Recruitment Status : Terminated (Sponsor ceased operations)
First Posted : March 28, 2017
Last Update Posted : October 10, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Information provided by (Responsible Party):
Cardialen, Inc.

Tracking Information
First Submitted Date  ICMJE March 13, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date October 10, 2022
Actual Study Start Date  ICMJE April 8, 2019
Actual Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2021)
Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm [ Time Frame: During study procedure ]
Assess the safety and performance of the Cardialen External Stimulation System and safety and performance ofUPT therapy
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm [ Time Frame: During study procedure ]
To assess the safety and performance of ventricular UPT therapy to terminate ventricular tachyarrhythmias
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Unpinning Termination Therapy for VT (US)
Official Title  ICMJE A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT
Brief Summary This observation study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.
Detailed Description This non-blinded, single-arm open-label, phase 1 pilot, acute research feasibility trial aims to demonstrate that the safety and effectiveness of Unpinning Termination (UPT) electrotherapy observed in the canine can be translated to humans and to demonstrate the safety and performance of UPT electrotherapy in the human population most likely to benefit from this therapy. This study evaluates the safety and performance of UPT therapy in subjects during either an indicated ventricular tachycardia (VT) catheter ablation or an indicated initial implant or device replacement of an implantable cardioverter defibrillator (ICD).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Patients undergoing a routine clinically indicated procedure will have the investigational therapy delivered during the clinically indicated procedure.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Ventricular Tachycardia
Intervention  ICMJE Device: Unpinning Termination therapy
Electrotherapy comprised of standard biphasic and monophasic pacing pulses
Other Names:
  • Multi-Stage Therapy
  • Multi-Stage Electrotherapy
Study Arms  ICMJE Experimental: UPT Treatment
Investigational therapy (UPT)
Intervention: Device: Unpinning Termination therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 7, 2022)
6
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
50
Actual Study Completion Date  ICMJE October 1, 2022
Actual Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The subject must meet all of the following inclusion criteria:

  1. Life expectancy of 1 year or greater
  2. Male or female between 18 and 80 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 symptomatic VT with use of CESS V1.0 or CESS V1.1 OR an indication for an ICD procedure (de novo implant, replacement or upgrade) or de novo CRTD procedure for the risk of or presence of VT (CESS 1.0 and 1.1)
  5. Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy
  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 at time of Study Procedure and no anticoagulation for preceding 3 weeks and no preoperative transesophageal echocardiographic, Cardiac CT or Intracardiac echocardiographic confirmation of the absence of LA thrombus
  4. Presence of intracardiac thrombus
  5. Inability to pass catheters to heart due to vascular limitations
  6. 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
  7. Pregnancy confirmed by test within 7 days of procedure
  8. Presence of a chronically implanted lead in the CS
  9. Presence of a ventricular assist device, including intra-aortic balloon pump
  10. Subjects indicated for VT ablation and experiencing VF
  11. Subjects requiring the use of inotropes and/or vasopressors for hemodynamic support within the 3 days prior to the study
  12. Prior VT catheter ablation with associated hemodynamic compromise despite pressor agents or stroke
  13. Incessant VT/VF or VT/VF storm within six months of scheduled procedure
  14. LVEF < 20%
  15. New York Heart Association (NYHA) Class IV heart failure
  16. Planned epicardial VT ablation on the same day as the research study
  17. History of hyper-coagulable state that could increase risk of thromboembolic events
  18. History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support
  19. Unstable coronary artery disease as determined by the investigator
  20. Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators
  21. History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months
  22. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis
  23. 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)
  24. Morbid obesity: BMI>39 kg/m2
  25. Cognitive or mental health status that would interfere with study participation and proper informed consent
  26. Presence of mechanical tricuspid valve
  27. Active Endocarditis
  28. Ventricular arrhythmia with etiology of sarcoid flare
  29. Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator
  30. End Stage Renal Disease on hemodialysis or peritoneal dialysis, or creatinine clearance <15 ml/min
  31. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03093051
Other Study ID Numbers  ICMJE CL005
2R44HL107055-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cardialen, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cardialen, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Washington University School of Medicine
Investigators  ICMJE
Principal Investigator: Daniel H. Cooper, MD Washington University School of Medicine
PRS Account Cardialen, Inc.
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP