Clinical Trials Logo

Clinical Trial Summary

This study is intended to develop a better method for stopping potentially lethal heart rhythms than currently available defibrillators. This new method, called Unpinning Termination Therapy (UPT), is hypothesized to be effective in stopping these dangerous heart rhythms at lower voltages and energy than current defibrillators. Consequently, UPT may improve survival, reduce patient pain from shocks, and lead to longer lasting and smaller implantable defibrillators.


Clinical Trial Description

A prospective single-arm feasibility study involving acute testing of UPT electrotherapy in subjects with VT/VF during clinically indicated ventricular tachycardia catheter ablation procedure or indicated implantable cardioverter defibrillator implant, upgrade, or replacement or new CRT-D implant or upgrade to CRT-D. The study involves up to two roll in subjects at each participating site followed by an UPT evaluation and refinement segment in which remaining subjects are enrolled until arrhythmia terminations from UPT delivery are reliably achieved. A prospective evaluation segment will be performed to compare UPT against SBS and ATP if sufficient subjects remain once reliable terminations from UPT are achieved. Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03871231
Study type Interventional
Source Cardialen, Inc.
Contact
Status Terminated
Phase N/A
Start date July 17, 2019
Completion date July 15, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03453645 - Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Completed NCT05791032 - Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study N/A
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Completed NCT04011631 - Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Enrolling by invitation NCT02962076 - Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia Early Phase 1
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Completed NCT01791543 - Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia N/A
Terminated NCT02891863 - Low Energy Therapy to Convert Ventricular Tachycardias Phase 0
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT01294267 - Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation N/A
Terminated NCT00383799 - Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT04642963 - Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia N/A
Recruiting NCT05377216 - Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation Early Phase 1
Not yet recruiting NCT04990089 - VIVO European Observational Registry
Completed NCT04065893 - Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Recruiting NCT03631303 - Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
Recruiting NCT03611465 - Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts N/A