A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Unpinning Termination Therapy in Patients With VT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Tachycardia
- Sponsor
- Cardialen, Inc.
- Enrollment
- 6
- Locations
- 7
- Primary Endpoint
- Arrhythmia Termination as assessed by the number of episodes restored to sinus rhythm
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
This non-blinded, single-arm open-label, 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 performance of UPT electrotherapy in the human population most likely to benefit from this therapy. This study evaluates the safety and performance 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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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