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Completed

NCT Number: NCT00982397

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

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.

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Key information

Conditions

Tachyarrhythmias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Ventricular Dysfunction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKH - Universitätsklinikum Graz, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protecta VR-ICD

Device

Protecta single-chamber implantable cardioverter defibrillators.

Protecta DR-ICD or CRT-D

Device

Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Primary outcomes

  1. 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 .

  2. 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.

  3. 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.

Secondary outcomes

  1. Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free

    Time frame: Implant to one year post-implant

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2009
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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