Safety and Clinical Performance of the Protecta ICD and CRT-D
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.
1 other identifier
interventional
2,770
21 countries
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedNovember 6, 2017
October 1, 2017
4 years
September 22, 2009
May 25, 2016
October 5, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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 .
Implant to one year post-implant
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.
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
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 Outcomes (1)
Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free
Implant to one year post-implant
Study Arms (2)
Single-chamber detetction
EXPERIMENTALPatients implanted with a Protecta VR-ICD.
Dual-chamber detection
EXPERIMENTALPatients implanted with a Protecta DR-ICD or CRT-D.
Interventions
Protecta single-chamber implantable cardioverter defibrillators.
Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 anticipated not being able to complete the study
- Patients unwilling to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
Birmingham Heart Clinic PC
Birmingham, Alabama, 35235, United States
CardioVasular Associates of Mesa
Mesa, Arizona, 85206, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
LA Cardiology Associates
Los Angeles, California, 90017, United States
Cardiology Consultants of Napa Valley
Napa, California, 94558, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
University of Florida Health at Jacksonville
Jacksonville, Florida, 32209, United States
Arrhythmia Syncope Consultants LLC
Miami, Florida, 33133, United States
Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
Cardiovascular Research of Northwest Indiana
Munster, Indiana, 46321, United States
Iowa Heart Center
West Des Moines, Iowa, 50314, United States
Delmarva Heart Research Foundation
Salisbury, Maryland, 21804, United States
Essentia Institute of Rural Health
Duluth, Minnesota, 55805, United States
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303, United States
Saint John's Medical Research Inc
Springfield, Missouri, 65804, United States
Saint Louis Heart & Vascular PC
St Louis, Missouri, 62040, United States
Cardiology PC
Syracuse, New York, 13210, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374, United States
Ohio Heart and Vascular
Cincinnati, Ohio, 45219, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Pee Dee Cardiology
Florence, South Carolina, 29506, United States
Cardiology Consultants PA
Spartanburg, South Carolina, 29303, United States
Centennial Heart Cardiovascular Consultants LLC
Nashville, Tennessee, 37203, United States
Hall-Garcia Cardiology Associates
Houston, Texas, 77030, United States
Virginia Commonwealth University Health System
Richmond, Virginia, 23298, United States
Spokane Cardiology
Spokane, Washington, 99204, United States
Columbia St. Mary's Hospital
Milwaukee, Wisconsin, 53211, United States
LKH - Universitätsklinikum Graz
Graz, Austria
Landesklinikum St. Pölten
Sankt Pölten, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
Saint Paul's Hospital (Vancouver BC)
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Institut Universitaire de Cardiologieet de Pneumologie de Québec (IUCPQ)
Halifax, Nova Scotia, Canada
Newmarket Electrophysiology Research Group
Newmarket, Ontario, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Canada
Kelowna Arrhythmia Research
Kelowna, Canada
Queen's University & Kingston General Hospital
Kingston, Canada
London Health Sciences Centre - University Campus
London, Canada
Montreal Heart Institute
Montreal, Canada
University of Ottawa Heart Institute
Ottawa, Canada
Fundacion Cardioinfantil
Bogotá, Colombia
Hospital Cardiovascular del Nino
Bogotá, Colombia
Clinica Cardiovascular Santa Maria
Medellín, Colombia
Krajska nemocnice Liberec a.s. - Kardiocentrum
Liberec, Czechia
Aalborg Sygehus
Aalborg, Denmark
Aarhus Universitetshospital - Skejby
Aarhus, Denmark
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, Germany
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
Bochum, Germany
Universitätsklinikum Bonn
Bonn, Germany
MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
Chemnitz, Germany
Klinikum Coburg GmbH
Coburg, Germany
Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
Frankfurt, Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Ruprecht-Karls-Universität
Heidelberg, Germany
Westpfalz-Klinikum GmbH - Standort I Kaiserslautern
Kaiserslautern, Germany
Herz Zentrum Bodensee
Konstanz, Germany
Klinikum Ludwigsburg - Akademisches Lehrkrankenhaus der Universität Heidelberg
Ludwigsburg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Städtische Kliniken München GmbH - Klinikum Bogenhausen
München, Germany
Städtische Kliniken Neuss Lukaskrankenhaus GmbH-Akad.Lehrkrankenhaus d. Heinrich-Heine-Universität
Neuss, Germany
Universitätsmedizin Rostock
Rostock, Germany
Herz- und Kreislaufzentrum Rotenburg a.d. Fulda GmbH
Rotenburg A.d. Fulda, Germany
Asklepios Kliniken Schwalm - Eder GmbH - Klinikum Schwalmstadt
Schwalmstadt, Germany
Heinrich-Braun-Klinikum Zwickau gemeinnützige GmbH
Zwickau, Germany
Care Institute of Medical Sciences
Ahmedabad, India
Medanta-The Medicity
Gūrgaon, India
Barzilai Medical Center Ashkelon
Ashkelon, Israel
Soroka University Medical Center
Be'er Sheba, Israel
Carmel Medical Center
Haifa, Israel
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
Negrar, Italy
Azienda Complesso Ospedaliero San Filippo Neri - Ospedale San Filippo Neri
Rome, Italy
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan
Kansai Rosai Hospital
Amagasak, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Kinki University Hospital
Osakasaya, Osaka, Japan
National Cerebral and Cardiovasuclar Center
Suita, Osaka, Japan
Sapporo Medical Center NTT EC
Chūōku, Sapporo, Japan
Akita Medical Center
Akita, Japan
Chiba University Hospital
Chiba, Japan
Kokura Memorial Hospital
Kitakyushu, Japan
Kumamoto University Hospital
Kumamoto, Japan
Kyoto University Hospital
Kyoto, Japan
Niigata University Medical & Dental Hospital
Niigata, Japan
Kitasato University Hospital
Sagamihara, Japan
Institut Jantung Negara - National Heart Institute
Kuala Lumpur, Malaysia
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands
Amphia Ziekenhuis - Locatie Molengracht Breda
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Prince Salman Heart Centre - King Fahad Medical City
Riyadh, Saudi Arabia
University Medical Centre Ljubljana
Ljubljana, Slovenia
Milpark Hospital
Johannesburg, South Africa
Hospital De Cruces
Barakaldo, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Complejo Hospitalario Universitario de Vigo (CHUVI) - Hospital del Meixoeiro
Vigo, Spain
Universitetssjukhuset i Lund
Lund, Sweden
Universitetssjukhuset Örebro
Örebro, Sweden
Capio S:t Görans Sjukhus
Stockholm, Sweden
Cardio Centro Ticino
Lugano, Switzerland
Sheikh Khalifa Medical Center
Abu Dhabi, United Arab Emirates
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Related Publications (6)
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.
PMID: 21669960BACKGROUNDAuricchio 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.
PMID: 25637563RESULTSterns 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.
PMID: 26988379RESULTWollmann 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.
PMID: 24665992RESULTZweibel 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.
PMID: 30478983DERIVEDKurita 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.
PMID: 29928759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CRHF Clinical Research
- Organization
- Medtronic, plc
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 23, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
November 6, 2017
Results First Posted
November 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share