Unpinning Termination Therapy for VT (US)

Stopped early · Not applicable

Conditions studied: Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT03093051

Run by

Cardialen, Inc.

People needed

6

Starts

2019-04-08

Expected to finish

2022-10-01

Last updated by the study team

2022-10-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mercy Medical Group — Sacramento, California, United States
• MercyOne Des Moines Medical Center — Des Moines, Iowa, United States
• Minneapolis VA Healthcare System — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• Baylor Scott & White Heart and Vascular Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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