Clinical trial NCT00982397: Safety and Clinical Performance of the Protecta ICD and CRT-D
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachyarrhythmias
Heart Failure
Ventricular Dysfunction
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 2770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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