NCT00982397

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,770 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tachyarrhythmias
• Heart Failure
• Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	Protecta VR-ICD	Protecta single-chamber implantable cardioverter defibrillators.
DEVICE	Protecta DR-ICD or CRT-D	Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2009-09-23
• Last updated: 2017-11-06
• Results posted: 2017-11-06

Locations

122 sites across 21 countries: United States, Austria, Canada, Colombia, Czechia, Denmark, Germany, India, Israel, Italy, Japan, Malaysia, Netherlands, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom