Safety and Clinical Performance of the Protecta ICD and CRT-D
|ClinicalTrials.gov Identifier: NCT00982397|
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tachyarrhythmias Heart Failure Ventricular Dysfunction||Device: Protecta VR-ICD Device: Protecta DR-ICD or CRT-D||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2770 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Single-chamber detetction
Patients implanted with a Protecta VR-ICD.
Device: Protecta VR-ICD
Protecta single-chamber implantable cardioverter defibrillators.
Experimental: Dual-chamber detection
Patients implanted with a Protecta DR-ICD or CRT-D.
Device: Protecta DR-ICD or CRT-D
Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
- Percentage of Subjects Who Are Inappropriate Shock Free [ Time Frame: Implant to one year post-implant ]Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .
- Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) [ Time Frame: Implant to one month post-implant ]In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
- Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off [ Time Frame: At implant ]In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.
- Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free [ Time Frame: Implant to one year post-implant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982397
Show 122 Study Locations
|Principal Investigator:||A. Meijer, Dr.||Eindhoven, The Netherlands|
|Principal Investigator:||A. Auricchio, Prof.||Lugano, Switzerland|
|Principal Investigator:||T. Kurita, Dr.||Higashi-Osaka, Japan|
|Principal Investigator:||E.J. Schloss, Dr.||Cincinnati Ohio, USA|
|Principal Investigator:||L. Sterns, Dr.||Victoria, British Columbia, Canada|