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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Tachyarrhythmias, Heart Failure, Ventricular Dysfunction

Intervention / Treatment
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* Device: Protecta VR-ICD
* Device: Protecta DR-ICD or CRT-D


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-chamber detetction<br>Patients implanted with a Protecta VR-ICD. | Device: Protecta VR-ICD<br>* Protecta single-chamber implantable cardioverter defibrillators.<br>|
| Experimental: Dual-chamber detection<br>Patients implanted with a Protecta DR-ICD or CRT-D. | Device: Protecta DR-ICD or CRT-D<br>* Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Are Inappropriate Shock Free | 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 . | Implant to one year post-implant | 
| Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) | 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. | Implant to one month post-implant | 
| 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 | 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. | At implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free |  | Implant to one year post-implant |