The STEP Study, sponsored by AtaCor Medical, is a first in man clinical trial evaluating the MACH I Delivery Tool combined with the STEALTH-TRAC Pacing lead as a single unit. The study enrolls up to 15 patients who will undergo acute and subacute testing of a temporary pacing systems safety and effectiveness. The Step Study is currently enrolling in Paraguay. The protocol and the device system being tested involves human prototypes that are based on the early feasibility and device development experiments that have been reported recently in Circulation: Arrhythmia and Electrophysiology.
Clinical Trials
CorVita Science Foundation is progressing patient care by delivering innovative therapies and cutting-edge research trials. Below is a list of our current trials.
S-ICD System Post Approval Study (S-ICD PAS)
The primary purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting. This study is sponsored by Boston Scientific Corporation Cardiac Rhythm Management (CRM)
Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low Ejection Fraction (UNTOUCHED)
The primary objective of this study is to assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200bpm and 250bpm. This study is sponsored by Boston Scientific Corporation.
Assessment of Primary Prevention Patients Receiving an ICD – Systematic Evaluation of ATP (APPRAISE-ATP)
The primary objective is to understand the role of anti-tachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy. The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency.
The use of the medication adherence score to predict non adherence in atrial fibrillation patients and improve patient selection for Watchman Therapy (ADHERE-AF)
The aim of this study is to assess how many atrial fibrillation (AF) patients in general AF population there are with predicted low adherence using the Medication Adherence Score (MAS).
MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
The objective of this multi-site research is to establish a contemporary and simple registry to help determine the course and progression of patients with atrial fibrillation (AF). Its main focus is the management of AF in the prevention of thrombo-embolic events using rhythm and rate control interventions.
PRAETORIAN-DFT
The primary objective is to determine whether the S-ICD implant without defibrillation testing using a new method of measurement (PRAETORIAN Score) is similar to the standard method of defibrillation testing with a totally subcutaneous implantable defibrillation system (S-ICD). The secondary objectives are to evaluate the PRAETORIAN score and to evaluate anesthesia protocols for implantation.