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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
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE September 22, 2009
First Posted Date  ICMJE September 23, 2009
Results First Submitted Date  ICMJE May 25, 2016
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • Percentage of subjects with unanticipated severe adverse device effects [ Time Frame: Implant to one month post-implant ]
  • Percentage of 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 ]
  • Percentage of Subjects Who Are Inappropriate Shock Free [ Time Frame: Implant to one year post-implant ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free [ Time Frame: Implant to one year post-implant ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2009)
  • Describe system performance [ Time Frame: Implant to one year post-implant ]
  • Effect of shocks on quality of life [ Time Frame: Implant to one year post-implant ]
  • Effect of shocks on health care utilization [ Time Frame: Implant to one year post-implant ]
  • Reasons for inappropriate shocks [ Time Frame: Implant to one year post-implant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Clinical Performance of the Protecta ICD and CRT-D
Official Title  ICMJE 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.
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tachyarrhythmias
  • Heart Failure
  • Ventricular Dysfunction
Intervention  ICMJE
  • Device: Protecta VR-ICD
    Protecta single-chamber implantable cardioverter defibrillators.
  • Device: Protecta DR-ICD or CRT-D
    Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Study Arms  ICMJE
  • Experimental: Single-chamber detetction
    Patients implanted with a Protecta VR-ICD.
    Intervention: Device: Protecta VR-ICD
  • Experimental: Dual-chamber detection
    Patients implanted with a Protecta DR-ICD or CRT-D.
    Intervention: Device: Protecta DR-ICD or CRT-D
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2017)
2770
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)
1131
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Colombia,   Czechia,   Denmark,   Germany,   India,   Israel,   Italy,   Japan,   Malaysia,   Netherlands,   Saudi Arabia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   United Arab Emirates,   United Kingdom,   United States
Removed Location Countries Chile,   Czech Republic,   Finland,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00982397
Other Study ID Numbers  ICMJE PainFree SST
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP