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Unpinning Termination Therapy for VT/VF (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093051
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : January 13, 2020
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 Device: 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).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT/VF
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021



Intervention Details:
  • 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 ]
    To assess the safety and performance of ventricular UPT therapy to terminate ventricular tachyarrhythmias



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 80 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 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) and/or VF (CESS 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 with use of CESS V1.0
  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, Genetic Cardiac Channelopathy, Cardiac Amyloidosis 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


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

Locations
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United States, California
Mills Peninsula Medical Center Recruiting
Burlingame, California, United States, 94010
Contact: Milena Ferreira       ferreiml@sutterhealth.org   
Principal Investigator: Christopher Woods, MD         
Mercy Medical Group Recruiting
Sacramento, California, United States, 95819
Contact: Shelley Allen    916-453-2626    Shelley.allen@dignityhealth.org   
Principal Investigator: P. Gearoid O'Neill, MD         
United States, Minnesota
Minneapolis VA Healthcare System Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Jill Morgan    612-467-2455    Jill.morgan@va.gov   
Principal Investigator: Venkatakrishna N Tholakanahalli, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Janice Amsler    314-747-8542    jmamsler@wustl.edu   
Principal Investigator: Daniel H Cooper, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan Gerstl    919-681-8983    Susan.Gerstl@duke.edu   
Principal Investigator: Brett Atwater, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Carrie Nowak    919-668-3524    Carrie.nowak@duke.edu   
Principal Investigator: Brett Atwater, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ashleigh Keiter       Ashleigh.keiter@osumc.edu   
Principal Investigator: John D Hummel, MD         
OhioHealth Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Audrey McDonald       Audrey.McDonald@ohiohealth.com   
Principal Investigator: Anish Amin, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-431-4868    dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, MD         
Sponsors and Collaborators
Cardialen, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Investigators
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Principal Investigator: Daniel H Cooper, MD Washington University School of Medicine
Publications:

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Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT03093051    
Other Study ID Numbers: CL005
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
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
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