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Termination Therapy for Ventricular Tachyarrhythmias (JUPITER)

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ClinicalTrials.gov Identifier: NCT03093051
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : April 16, 2019
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 March 13, 2017
First Posted Date March 28, 2017
Last Update Posted Date April 16, 2019
Actual Study Start Date March 12, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03093051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Termination Therapy for Ventricular Tachyarrhythmias
Official Title Unpinning Pulse Termination Therapy for Ventricular Tachyarrhythmias
Brief Summary This observation study evaluates the safety and effectiveness 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, non-significant risk, 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 effectiveness of UPT electrotherapy in the human population most likely to benefit from this therapy. This observation study evaluates the safety and effectiveness 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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will be performed in patients indicated and subsequently undergoing catheter ablation of VT/VF or the implant of an implantable cardioverter defibrillator.
Condition
  • Ventricular Fibrillation
  • Ventricular Tachycardia
Intervention Device: Unpinning Termination therapy
Electrotherapy comprised of standard biphasic and monophasic pacing pulses
Other Names:
  • Multi-Stage Therapy
  • Multi-Stage Electrotherapy
Study Groups/Cohorts Not Provided
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 Recruiting
Estimated Enrollment
 (submitted: March 22, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Life expectancy of 1 year or greater
  2. Male or female between 18 and 75 years of age
  3. Willingness and ability to comply with the study protocol, including providing a written, informed consent
  4. Subject indicated for a cardiac catheter ablation procedure for sustained VT/VF or non-sustained VT with associated electrophysiology study OR subject indicated for implantable cardioverter defibrillator implant or replacement that, at time of study consent, are medically stable to undergo defibrillation safety margin testing procedure performed under 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 to undergo defibrillation testing
  2. Hemodynamic instability as determined by the investigator
  3. Prior VT ablation with history of hemodynamic compromise
  4. Atrial Tachyarrhythmia (AT/AFl/AF) at time of study procedure
  5. Incessant VT/VF
  6. Inability to Tolerate Systemic Anticoagulation
  7. LVEF < 15%
  8. New York Heart Association (NYHA) Class IV
  9. History of intracardiac thrombus
  10. History of hyper-coagulable state that increases risk of thrombus
  11. History of hemodynamic compromise severe aortic stenosis
  12. Inability to Pass Catheters to Heart Due to Vascular Limitations
  13. 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
  14. Unstable CAD as determined by the investigator
  15. Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigators
  16. History of embolic stroke, Transient Ischemic Attack or other thromboembolic event
  17. History of Hypertrophic Cardiomyopathy, or Arrhythmogenic RV Dysplasia
  18. 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)
  19. Pregnancy confirmed by test within 7 days of procedure
  20. Pacemaker Dependency
  21. Morbid obesity: BMI>39 kg/m2
  22. Medically unstable at time of study to undergo defibrillation testing
  23. Cognitive or mental health status that would interfere with study participation and proper informed consent
  24. Presence of other permanently implanted medical devices (e.g. artificial cardiac valves) that may affect the outcomes of this study or safety of the subject, as determined by the investigator (except ICD)
  25. History of significant Peripheral Vascular Disease, including peripheral vascular interventions and IVC filter placement
  26. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dave Munneke, MS 6128049516 DMunneke@cardialen.com
Contact: Tom Rasmussen, BA 7196596363 trasmussen@cardialen.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03093051
Other Study ID Numbers CL005
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cardialen, Inc.
Study Sponsor Cardialen, Inc.
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Washington University School of Medicine
Investigators
Principal Investigator: Daniel H Cooper, MD Washington University School of Medicine
PRS Account Cardialen, Inc.
Verification Date April 2019