Safety and Clinical Performance of the Protecta ICD and CRT-D
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982397
|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|