We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Unpinning Termination Therapy for VT (US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03093051
Recruitment Status : Terminated (Sponsor ceased operations)
First Posted : March 28, 2017
Last Update Posted : October 10, 2022
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 performance of UPT therapy in subjects during either an indicated ventricular tachycardia ablation procedure or an ICD implant procedure.

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

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Official Title: A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : October 1, 2022
Actual Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: UPT Treatment
Investigational therapy (UPT)
Device: 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 ]
    Assess the safety and performance of the Cardialen External Stimulation System and safety and performance ofUPT therapy

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Layout table for location information
United States, California
Mercy Medical Group
Sacramento, California, United States, 95819
United States, Iowa
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States, 50314
United States, Minnesota
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Texas
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Cardialen, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Layout table for investigator information
Principal Investigator: Daniel H. Cooper, MD Washington University School of Medicine

Layout table for additonal information
Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT03093051    
Other Study ID Numbers: CL005
2R44HL107055-02 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cardialen, Inc.:
Additional relevant MeSH terms:
Layout table for MeSH terms
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes