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

October 5, 2017 updated by: Medtronic Cardiac Rhythm and Heart Failure

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

2770

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • LKH - Universitätsklinikum Graz
      • St. Polten, Austria
        • Landesklinikum St. Pölten
      • Wels, Austria
        • Klinikum Wels-Grieskirchen GmbH
  • Canada
      • Halifax, Canada
        • Queen Elizabeth Ii Health Sciences Centre
      • Kelowna, Canada
        • Kelowna Arrhythmia Research
      • Kingston, Canada
        • Queen's University & Kingston General Hospital
      • London, Canada
        • London Health Sciences Centre - University Campus
      • Montreal, Canada
        • Montreal Heart Institute
      • Ottawa, Canada
        • University of Ottawa Heart Institute
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hospital (Vancouver BC)
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Institut Universitaire de Cardiologieet de Pneumologie de Québec (IUCPQ)
    • Ontario
      • Newmarket, Ontario, Canada
        • Newmarket Electrophysiology Research Group
  • Colombia
      • Bogota, Colombia
        • Fundacion Cardioinfantil
      • Bogota, Colombia
        • Hospital Cardiovascular del Nino
      • Medellin, Colombia
        • Clinica Cardiovascular Santa Maria
  • Czechia
      • Liberec, Czechia
        • Krajska nemocnice Liberec a.s. - Kardiocentrum
  • Denmark
      • Aalborg, Denmark
        • Aalborg Sygehus
      • Aarhus, Denmark
        • Aarhus Universitetshospital - Skejby
  • Germany
      • Bad Bevensen, Germany
        • Herz- und Gefasszentrum Bad Bevensen
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
      • Bad Segeberg, Germany
        • Segeberger Kliniken GmbH
      • Bochum, Germany
        • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
      • Bonn, Germany
        • Universitätsklinikum Bonn
      • Chemnitz, Germany
        • MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
      • Coburg, Germany
        • Klinikum Coburg GmbH
      • Frankfurt, Germany
        • Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
      • Gottingen, Germany
        • Universitätsmedizin Göttingen Georg-August-Universität
      • Heidelberg, Germany
        • Ruprecht-Karls-Universität
      • Kaiserslautern, Germany
        • Westpfalz-Klinikum GmbH - Standort I Kaiserslautern
      • Konstanz, Germany
        • Herz Zentrum Bodensee
      • Ludwigsburg, Germany
        • Klinikum Ludwigsburg - Akademisches Lehrkrankenhaus der Universität Heidelberg
      • Mainz, Germany
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Munchen, Germany
        • Städtische Kliniken München GmbH - Klinikum Bogenhausen
      • Neuss, Germany
        • Städtische Kliniken Neuss Lukaskrankenhaus GmbH-Akad.Lehrkrankenhaus d. Heinrich-Heine-Universität
      • Rostock, Germany
        • Universitätsmedizin Rostock
      • Rotenburg a.d. Fulda, Germany
        • Herz- und Kreislaufzentrum Rotenburg a.d. Fulda GmbH
      • Schwalmstadt, Germany
        • Asklepios Kliniken Schwalm - Eder GmbH - Klinikum Schwalmstadt
      • Zwickau, Germany
        • Heinrich-Braun-Klinikum Zwickau gemeinnützige GmbH
  • India
      • Ahmedabad, India
        • Care Institute of Medical Sciences
      • Gurgaon, India
        • Medanta-The Medicity
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center Ashkelon
      • Be'er Sheba, Israel
        • Soroka University Medical Center
      • Haifa, Israel
        • Rambam Health Care Campus
      • Haifa, Israel
        • Carmel Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Petach Tikva, Israel
        • Rabin Medical Center - Beilinson Hospital
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Negrar, Italy
        • Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
      • Rome, Italy
        • Azienda Complesso Ospedaliero San Filippo Neri - Ospedale San Filippo Neri
  • Japan
      • Akita, Japan
        • Akita Medical Center
      • Chiba, Japan
        • Chiba University Hospital
      • Kitakyushu, Japan
        • Kokura Memorial Hospital
      • Kumamoto, Japan
        • Kumamoto University Hospital
      • Kyoto, Japan
        • Kyoto University Hospital
      • Niigata, Japan
        • Niigata University Medical & Dental Hospital
      • Sagamihara, Japan
        • Kitasato University Hospital
    • Aomori
      • Hirosaki, Aomori, Japan
        • Hirosaki University School of Medicine & Hospital
    • Hyogo
      • Amagasak, Hyogo, Japan
        • Kansai Rosai Hospital
      • Kobe, Hyogo, Japan
        • Kobe University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • St. Marianna University School of Medicine Hospital
    • Osaka
      • Osakasaya, Osaka, Japan
        • Kinki University Hospital
      • Suita, Osaka, Japan
        • National Cerebral and Cardiovasuclar Center
    • Sapporo
      • Chuo-ku, Sapporo, Japan
        • Sapporo Medical Center NTT EC
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara - National Heart Institute
  • Netherlands
      • Alkmaar, Netherlands
        • Medisch Centrum Alkmaar
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum (AMC)
      • Breda, Netherlands
        • Amphia Ziekenhuis - Locatie Molengracht Breda
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Leiden, Netherlands
        • Leids Universitair Medisch Centrum
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Utrecht, Netherlands
        • Universitair Medisch Centrum Utrecht
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Faisal Specialist Hospital & Research Center
      • Riyadh, Saudi Arabia
        • Prince Salman Heart Centre - King Fahad Medical City
  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Centre Ljubljana
  • South Africa
      • Johannesburg, South Africa
        • Milpark Hospital
  • Spain
      • Barakaldo, Spain
        • Hospital de Cruces
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Vigo, Spain
        • Complejo Hospitalario Universitario de Vigo (CHUVI) - Hospital del Meixoeiro
  • Sweden
      • Lund, Sweden
        • Universitetssjukhuset i Lund
      • Stockholm, Sweden
        • Capio S:t Görans Sjukhus
      • Örebro, Sweden
        • Universitetssjukhuset Örebro
  • Switzerland
      • Lugano, Switzerland
        • Cardio Centro Ticino
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Sheikh Khalifa Medical Center
  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom
        • King's College Hospital NHS Foundation Trust
      • Southampton, United Kingdom
        • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Birmingham Heart Clinic PC
    • Arizona
      • Mesa, Arizona, United States, 85206
        • CardioVasular Associates of Mesa
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
    • California
      • Los Angeles, California, United States, 90017
        • LA Cardiology Associates
      • Napa, California, United States, 94558
        • Cardiology Consultants of Napa Valley
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health at Jacksonville
      • Miami, Florida, United States, 33133
        • Arrhythmia Syncope Consultants LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Heart Physicians
      • Munster, Indiana, United States, 46321
        • Cardiovascular Research of Northwest Indiana
    • Iowa
      • West Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • Delmarva Heart Research Foundation
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Institute of Rural Health
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart & Vascular Center
    • Missouri
      • Saint Louis, Missouri, United States, 62040
        • Saint Louis Heart & Vascular PC
      • Springfield, Missouri, United States, 65804
        • Saint John's Medical Research Inc
    • New York
      • Syracuse, New York, United States, 13210
        • Cardiology PC
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Pinehurst Medical Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Ohio Heart and Vascular
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Medical Center
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Central Bucks Cardiology
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Florence, South Carolina, United States, 29506
        • Pee Dee Cardiology
      • Spartanburg, South Carolina, United States, 29303
        • Cardiology Consultants PA
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Centennial Heart Cardiovascular Consultants LLC
    • Texas
      • Houston, Texas, United States, 77030
        • Hall-Garcia Cardiology Associates
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Health System
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Cardiology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Implant to one year post-implant
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.
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
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.
At implant

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PainFree SST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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