Safety and Clinical Performance of the Protecta ICD and CRT-D

Heart Failure Clinical Trial

Official title: 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.

Status Completed

Clinical Trial 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.

Clinical Trial Description

The PainFree SST study was a prospective, multicenter clinical trial, which was conducted in two consecutive phases. Phase I assessed safety as determined by assessment of delays in ventricular fibrillation (VF) arrhythmia detection time using new algorithms. Phase II assessed the influence of new algorithms on inappropriate and unnecessary shocks at 1 year of follow-up. Subjects enrolled in Phase I continued in Phase II of the study and data from all enrolled subjects contributed to the analysis of Phase II objectives. A sub-study of Phase II randomized secondary prevention subjects to either 18/24 NID or 30/40 NID in order to assess the safety of prolonged detection in these patients. ;

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmias
• Tachycardia
• Ventricular Dysfunction

• NCT number: NCT00982397
• Study type: Interventional
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Completion date: September 2013