A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT

Status: Terminated
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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

Locations
United States
California
Mercy Medical Group
Sacramento
Iowa
MercyOne Des Moines Medical Center
Des Moines
Minnesota
Minneapolis VA Healthcare System
Minneapolis
Missouri
Washington University
Saint Louis
Ohio
OhioHealth Riverside Methodist Hospital
Columbus
The Ohio State University Wexner Medical Center
Columbus
Texas
Baylor Scott & White Heart and Vascular Hospital
Dallas
Time Frame
Start Date: April 8, 2019
Completion Date: October 1, 2022
Participants
Target number of participants: 6
Treatments
Experimental: UPT Treatment
Investigational therapy (UPT)
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Washington University School of Medicine
Leads: Cardialen, Inc.

This content was sourced from clinicaltrials.gov

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