N/A
N=236
Safety and Clinical Performance of the Protecta ICD and CRT-D
Tachyarrhythmias · Heart Failure · Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00982397 ↗Enrolled (actual)
236
Serious AEs
20.8%
Results posted
Nov 2017
Primary outcome: Primary: Percentage of Subjects Who Are Inappropriate Shock Free — 98.5; 97.5 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Protecta VR-ICD (Device); Protecta DR-ICD or CRT-D (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Are Inappropriate Shock Free |
98.5; 97.5 | — |
| PRIMARY Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) |
— | <0.0001 sig |
| PRIMARY 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 |
100 | <0.0001 sig |
| SECONDARY Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free |
96; 96 | 0.0013 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Patients meeting one of the following criteria can be included in Phase I of the study:
- Patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (DR-ICD)/cardiac resynchronization therapy defibrillator (CRT-D)
- Patients undergoing a device replacement or upgrade to DR-ICD or CRT-D and with the protocol required leads (patients must be enrolled prior to implant)
- Patients meeting one of the following criteria can be included in Phase II of the study:
- Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a Protecta device
- Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade to a Protecta DR-ICD/VR-ICD or CRT-D
- Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta device and the protocol required leads, who have not yet been discharged after implant
Exclusion Criteria
- Patients with a mechanical tricuspid heart valve
- Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
- Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
- Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc)
- Patients anticipated not being able to complete the study
- Patients unwilling to provide written informed consent
Data sourced from ClinicalTrials.gov (NCT00982397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.