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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ventricular Tachycardia | Device: Unpinning Termination therapy | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: UPT Treatment
Investigational therapy (UPT)
|
Device: Unpinning Termination therapy
Electrotherapy comprised of standard biphasic and monophasic pacing pulses
Other Names:
|
- 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

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.
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:
- Life expectancy of 1 year or greater
- Male or female between 18 and 80 years of age
- Willing and able to comply with the study protocol, provide a written informed consent
- 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)
- Etiology of arrhythmia, or risk of arrhythmia being ischemic cardiomyopathy or non-ischemic cardiomyopathy
- 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:
- Medically unstable at time of study and unsafe to undergo DFT testing under general anesthesia or conscious sedation as determined by the investigator
- Hemodynamic instability as determined by the investigator
- 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
- Presence of intracardiac thrombus
- Inability to pass catheters to heart due to vascular limitations
- 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
- Pregnancy confirmed by test within 7 days of procedure
- Presence of a chronically implanted lead in the CS
- Presence of a ventricular assist device, including intra-aortic balloon pump
- Subjects indicated for VT ablation and experiencing VF
- Subjects requiring the use of inotropes and/or vasopressors for hemodynamic support within the 3 days prior to the study
- Prior VT catheter ablation with associated hemodynamic compromise despite pressor agents or stroke
- Incessant VT/VF or VT/VF storm within six months of scheduled procedure
- LVEF < 20%
- New York Heart Association (NYHA) Class IV heart failure
- Planned epicardial VT ablation on the same day as the research study
- History of hyper-coagulable state that could increase risk of thromboembolic events
- History of hemodynamic compromise due to valvular heart disease requiring IV inotropes or other circulatory support
- Unstable coronary artery disease as determined by the investigator
- Severe proximal three-vessel or left main coronary artery disease, without revascularization as determined by the investigators
- History of embolic stroke, Transient Ischemic Attack or other thromboembolic event in the past 6 months
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis, Genetic Cardiac Channelopathy or Cardiac Sarcoidosis
- 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)
- Morbid obesity: BMI>39 kg/m2
- Cognitive or mental health status that would interfere with study participation and proper informed consent
- Presence of mechanical tricuspid valve
- Active Endocarditis
- Ventricular arrhythmia with etiology of sarcoid flare
- Previously implanted lead is under recall by manufacturer or evidence of lead failure as determined by the investigator
- End Stage Renal Disease on hemodialysis or peritoneal dialysis, or creatinine clearance <15 ml/min
- Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator

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
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 |
Principal Investigator: | Daniel H. Cooper, MD | Washington University School of Medicine |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Termination Unpinning Therapy |
Tachycardia Tachycardia, Ventricular Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Pathologic Processes |