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TachyarrhythmiasNCT00982397

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

A study testing Protecta VR-ICD and Protecta DR-ICD or CRT-D in people with Tachyarrhythmias and Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 122 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Protecta VR-ICD and Protecta DR-ICD or CRT-D
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,770 participants
Where
122 sitesin 21 countries
Study dates
Sep 2009to Sep 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

122 sites in 21 countries.

122 sites in 21 countries

United States29 sites

  • Birmingham Heart Clinic PC

    Birmingham, Alabama, 35235

  • Ohio Heart and Vascular

    Cincinnati, Ohio, 45219

  • Central Bucks Cardiology

    Doylestown, Pennsylvania, 18901

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805

  • Pee Dee Cardiology

    Florence, South Carolina, 29506

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Hall-Garcia Cardiology Associates

    Houston, Texas, 77030

  • Indiana Heart Physicians

    Indianapolis, Indiana, 46237

  • University of Florida Health at Jacksonville

    Jacksonville, Florida, 32209

  • LA Cardiology Associates

    Los Angeles, California, 90017

  • CardioVasular Associates of Mesa

    Mesa, Arizona, 85206

  • Arrhythmia Syncope Consultants LLC

    Miami, Florida, 33133

  • Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211

  • Cardiovascular Research of Northwest Indiana

    Munster, Indiana, 46321

  • Cardiology Consultants of Napa Valley

    Napa, California, 94558

  • Centennial Heart Cardiovascular Consultants LLC

    Nashville, Tennessee, 37203

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23298

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303

  • Delmarva Heart Research Foundation

    Salisbury, Maryland, 21804

  • Cardiology Consultants PA

    Spartanburg, South Carolina, 29303

  • Spokane Cardiology

    Spokane, Washington, 99204

  • Saint John's Medical Research Inc

    Springfield, Missouri, 65804

  • Saint Louis Heart & Vascular PC

    St Louis, Missouri, 62040

  • Cardiology PC

    Syracuse, New York, 13210

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Iowa Heart Center

    West Des Moines, Iowa, 50314

Other trials in United States

Germany20 sites

  • Herz- und Gefässzentrum Bad Bevensen

    Bad Bevensen

  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

    Bad Oeynhausen

  • Segeberger Kliniken GmbH

    Bad Segeberg

  • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

    Bochum

  • Universitätsklinikum Bonn

    Bonn

  • MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

    Chemnitz

  • Klinikum Coburg GmbH

    Coburg

  • Kardiocentrum Frankfurt an der Klinik Rotes Kreuz

    Frankfurt

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen

  • Ruprecht-Karls-Universität

    Heidelberg

  • Westpfalz-Klinikum GmbH - Standort I Kaiserslautern

    Kaiserslautern

  • Herz Zentrum Bodensee

    Konstanz

  • Klinikum Ludwigsburg - Akademisches Lehrkrankenhaus der Universität Heidelberg

    Ludwigsburg

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz

  • Städtische Kliniken München GmbH - Klinikum Bogenhausen

    München

  • Städtische Kliniken Neuss Lukaskrankenhaus GmbH-Akad.Lehrkrankenhaus d. Heinrich-Heine-Universität

    Neuss

  • Universitätsmedizin Rostock

    Rostock

  • Herz- und Kreislaufzentrum Rotenburg a.d. Fulda GmbH

    Rotenburg A.d. Fulda

  • Asklepios Kliniken Schwalm - Eder GmbH - Klinikum Schwalmstadt

    Schwalmstadt

  • Heinrich-Braun-Klinikum Zwickau gemeinnützige GmbH

    Zwickau

Other trials in Germany

Japan14 sites

  • Akita Medical Center

    Akita

  • Kansai Rosai Hospital

    Amagasak, Hyōgo

  • Chiba University Hospital

    Chiba

  • Sapporo Medical Center NTT EC

    Chūōku, Sapporo

  • Hirosaki University School of Medicine & Hospital

    Hirosaki, Aomori

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa

  • Kokura Memorial Hospital

    Kitakyushu

  • Kobe University Hospital

    Kobe, Hyōgo

  • Kumamoto University Hospital

    Kumamoto

  • Kyoto University Hospital

    Kyoto

  • Niigata University Medical & Dental Hospital

    Niigata

  • Kinki University Hospital

    Osakasaya, Osaka

  • Kitasato University Hospital

    Sagamihara

  • National Cerebral and Cardiovasuclar Center

    Suita, Osaka

Other trials in Japan

Canada10 sites

  • Institut Universitaire de Cardiologieet de Pneumologie de Québec (IUCPQ)

    Halifax, Nova Scotia

  • Queen Elizabeth II Health Sciences Centre

    Halifax

  • Kelowna Arrhythmia Research

    Kelowna

  • Queen's University & Kingston General Hospital

    Kingston

  • London Health Sciences Centre - University Campus

    London

  • Montreal Heart Institute

    Montreal

  • Newmarket Electrophysiology Research Group

    Newmarket, Ontario

  • University of Ottawa Heart Institute

    Ottawa

  • Saint Paul's Hospital (Vancouver BC)

    Vancouver, British Columbia

  • Royal Jubilee Hospital

    Victoria, British Columbia

Other trials in Canada

Israel9 sites

  • Barzilai Medical Center Ashkelon

    Ashkelon

  • Soroka University Medical Center

    Be'er Sheba

  • Carmel Medical Center

    Haifa

  • Rambam Health Care Campus

    Haifa

  • Shaare Zedek Medical Center

    Jerusalem

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva

  • Chaim Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center

    Rehovot

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Netherlands9 sites

  • Medisch Centrum Alkmaar

    Alkmaar

  • Academisch Medisch Centrum (AMC)

    Amsterdam

  • Amphia Ziekenhuis - Locatie Molengracht Breda

    Breda

  • Catharina Ziekenhuis

    Eindhoven

  • Medisch Spectrum Twente

    Enschede

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Leids Universitair Medisch Centrum

    Leiden

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Universitair Medisch Centrum Utrecht

    Utrecht

Other trials in Netherlands

Spain4 sites

  • Hospital De Cruces

    Barakaldo

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

  • Complejo Hospitalario Universitario de Vigo (CHUVI) - Hospital del Meixoeiro

    Vigo

Other trials in Spain

United Kingdom4 sites

  • Royal Bournemouth Hospital

    Bournemouth

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool

  • King's College Hospital NHS Foundation Trust

    London

  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

    Southampton

Other trials in United Kingdom

Austria3 sites

  • LKH - Universitätsklinikum Graz

    Graz

  • Landesklinikum St. Pölten

    Sankt Pölten

  • Klinikum Wels-Grieskirchen GmbH

    Wels

Other trials in Austria

Colombia3 sites

  • Fundacion Cardioinfantil

    Bogotá

  • Hospital Cardiovascular del Nino

    Bogotá

  • Clinica Cardiovascular Santa Maria

    Medellín

Other trials in Colombia

Sweden3 sites

  • Universitetssjukhuset i Lund

    Lund

  • Universitetssjukhuset Örebro

    Örebro

  • Capio S:t Görans Sjukhus

    Stockholm

Other trials in Sweden

Denmark2 sites

  • Aalborg Sygehus

    Aalborg

  • Aarhus Universitetshospital - Skejby

    Aarhus

Other trials in Denmark

India2 sites

  • Care Institute of Medical Sciences

    Ahmedabad

  • Medanta-The Medicity

    Gūrgaon

Other trials in India

Italy2 sites

  • Ospedale classificato ed equiparato Sacro Cuore - Don Calabria

    Negrar

  • Azienda Complesso Ospedaliero San Filippo Neri - Ospedale San Filippo Neri

    Rome

Other trials in Italy

Saudi Arabia2 sites

  • King Faisal Specialist Hospital & Research Center

    Riyadh

  • Prince Salman Heart Centre - King Fahad Medical City

    Riyadh

Other trials in Saudi Arabia

Czechia1 site

  • Krajska nemocnice Liberec a.s. - Kardiocentrum

    Liberec

Other trials in Czechia

Malaysia1 site

  • Institut Jantung Negara - National Heart Institute

    Kuala Lumpur

Other trials in Malaysia

Slovenia1 site

  • University Medical Centre Ljubljana

    Ljubljana

Other trials in Slovenia

South Africa1 site

  • Milpark Hospital

    Johannesburg

Other trials in South Africa

Switzerland1 site

  • Cardio Centro Ticino

    Lugano

Other trials in Switzerland

United Arab Emirates1 site

  • Sheikh Khalifa Medical Center

    Abu Dhabi

Other trials in United Arab Emirates

About this study

Official 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.

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.

Read the 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.

Being tested
Protecta VR-ICD, Protecta DR-ICD or CRT-D
Medical subject headings
Tachycardia, Heart Failure, Ventricular Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protecta VR-ICDDevice

    Protecta single-chamber implantable cardioverter defibrillators.

  • Protecta DR-ICD or CRT-DDevice

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

Study groups in NCT00982397
Study groupRoleWhat they receive
Single-chamber detetctionExperimentalPatients implanted with a Protecta VR-ICD.
Receives: Device: Protecta VR-ICD
Dual-chamber detectionExperimentalPatients implanted with a Protecta DR-ICD or CRT-D.
Receives: Device: Protecta DR-ICD or CRT-D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 .

    Measured: Implant to one year post-implant

  2. 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.

    Measured: Implant to one month post-implant

  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

    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.

    Measured: At implant

Secondary outcomes (1)

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

    Measured: Implant to one year post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00982397
Sponsor's protocol ID
PainFree SST
Status last verified
Oct 2017
First submitted
22 Sep 2009
Last updated
6 Nov 2017
Data monitoring committee
No
Individual data sharing
No

Publications

  • Auricchio A, Meijer A, Kurita T, Schloss E, Brinkman K, Claessens-van Ooijen M, Sterns L. Safety, efficacy, and performance of new discrimination algorithms to reduce inappropriate and unnecessary shocks: the PainFree SST clinical study design. Europace. 2011 Oct;13(10):1484-93. doi: 10.1093/europace/eur133. Epub 2011 Jun 13.

    PubMed 21669960

  • Auricchio A, Schloss EJ, Kurita T, Meijer A, Gerritse B, Zweibel S, AlSmadi FM, Leng CT, Sterns LD; PainFree SST Investigators. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. 2015 May;12(5):926-36. doi: 10.1016/j.hrthm.2015.01.017. Epub 2015 Jan 28.

    PubMed 25637563

  • Sterns LD, Meine M, Kurita T, Meijer A, Auricchio A, Ando K, Leng CT, Okumura K, Sapp JL, Brown ML, Lexcen DR, Gerritse B, Schloss EJ. Extended detection time to reduce shocks is safe in secondary prevention patients: The secondary prevention substudy of PainFree SST. Heart Rhythm. 2016 Jul;13(7):1489-96. doi: 10.1016/j.hrthm.2016.03.022. Epub 2016 Mar 14.

    PubMed 26988379

  • Wollmann CG, Lawo T, Kuhlkamp V, Becker R, Garutti C, Jackson T, Brown ML, Mayr H. Implantable defibrillators with enhanced detection algorithms: detection performance and safety results from the PainFree SST study. Pacing Clin Electrophysiol. 2014 Sep;37(9):1198-209. doi: 10.1111/pace.12390. Epub 2014 Mar 25.

    PubMed 24665992

  • Zweibel S, Cronin EM, Schloss EJ, Auricchio A, Kurita T, Sterns LD, Gerritse B, Lexcen DR, Cheng A. Estimating the incidence of atrial fibrillation in single-chamber implantable cardioverter defibrillator patients. Pacing Clin Electrophysiol. 2019 Feb;42(2):132-138. doi: 10.1111/pace.13555. Epub 2018 Dec 13.

    PubMed 30478983

  • Kurita T, Ando K, Ueda M, Shizuta S, Okamura H, Matsumoto N, Gerritse B, Fagan DH, Schloss EJ, Meijer A, Auricchio A, Sterns LD, Okumura K; PainFree SST investigators. Comparison of ICD shock rates in Japanese and non-Japanese patients in the PainFree SST study. Pacing Clin Electrophysiol. 2018 Sep;41(9):1185-1191. doi: 10.1111/pace.13427. Epub 2018 Aug 13.

    PubMed 29928759

Questions about this trial

What is this clinical trial studying?

A study testing Protecta VR-ICD and Protecta DR-ICD or CRT-D in people with Tachyarrhythmias and Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 122 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Germany, Japan, Canada, Israel and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Are Inappropriate Shock Free (time frame: Implant to one year post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00982397, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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