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Trial record 5 of 14 for:    implantable cardioverter defibrillator OR ICD | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Termination Therapy for Ventricular Tachyarrhythmias (JUPITER)

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ClinicalTrials.gov Identifier: NCT03093051
Recruitment Status : Not yet recruiting
First Posted : March 28, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Information provided by (Responsible Party):
Cardialen, Inc.

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.

Condition or disease Intervention/treatment
Ventricular Fibrillation Ventricular Tachycardia Other: Unpinning Termination therapy

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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Unpinning Pulse Termination Therapy for Ventricular Tachyarrhythmias
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021



Intervention Details:
  • Other: Unpinning Termination therapy
    Electrotherapy comprised of standard biphasic and monophasic pacing pulses
    Other Names:
    • Multi-Stage Therapy
    • Multi-Stage Electrotherapy


Primary Outcome Measures :
  1. 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



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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
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.
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

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): NCT03093051


Contacts
Contact: Michael B Shelton, MSEE 6125999311 bshelton@cardialen.com

Sponsors and Collaborators
Cardialen, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine

Publications:

Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT03093051     History of Changes
Other Study ID Numbers: CL005
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cardialen, Inc.:
Termination
Unpinning
Therapy

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes