At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The PainFree SST Clinical Study: Clinical Study to Evaluate System Safety and Clinical Performance of the Protecta ICD + CRT-D and to Assess the Capacity of the Protecta Features to Reduce Inappropriate Shocks.
In Brief
A clinical study evaluating Protecta VR-ICD and Protecta DR-ICD or CRT-D for Tachyarrhythmias and 2 related conditions. Completed, enrolled 2,770 participants across 122 sites in 21 countries.
Detailed Summary
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.
Study Details
Timeline
Interventions
Protecta single-chamber implantable cardioverter defibrillators.
Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.