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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2770

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitatsklinikum 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 Orebro
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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