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

Primary Purpose

Tachyarrhythmias, Heart Failure, Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Protecta VR-ICD
Protecta DR-ICD or CRT-D
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachyarrhythmias

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Heart Clinic PC
  • CardioVasular Associates of Mesa
  • Mercy Hospital Fort Smith
  • LA Cardiology Associates
  • Cardiology Consultants of Napa Valley
  • Hartford Hospital
  • University of Florida Health at Jacksonville
  • Arrhythmia Syncope Consultants LLC
  • Indiana Heart Physicians
  • Cardiovascular Research of Northwest Indiana
  • Iowa Heart Center
  • Delmarva Heart Research Foundation
  • Essentia Institute of Rural Health
  • CentraCare Heart & Vascular Center
  • Saint Louis Heart & Vascular PC
  • Saint John's Medical Research Inc
  • Cardiology PC
  • Pinehurst Medical Clinic
  • Ohio Heart and Vascular
  • St. Vincent Mercy Medical Center
  • Central Bucks Cardiology
  • University of Pennsylvania
  • Pee Dee Cardiology
  • Cardiology Consultants PA
  • Centennial Heart Cardiovascular Consultants LLC
  • Hall-Garcia Cardiology Associates
  • Virginia Commonwealth University Health System
  • Spokane Cardiology
  • Columbia St. Mary's Hospital
  • LKH - Universitätsklinikum Graz
  • Landesklinikum St. Pölten
  • Klinikum Wels-Grieskirchen GmbH
  • Saint Paul's Hospital (Vancouver BC)
  • Royal Jubilee Hospital
  • Institut Universitaire de Cardiologieet de Pneumologie de Québec (IUCPQ)
  • Newmarket Electrophysiology Research Group
  • Queen Elizabeth II Health Sciences Centre
  • Kelowna Arrhythmia Research
  • Queen's University & Kingston General Hospital
  • London Health Sciences Centre - University Campus
  • Montreal Heart Institute
  • University of Ottawa Heart Institute
  • Fundacion Cardioinfantil
  • Hospital Cardiovascular del Nino
  • Clinica Cardiovascular Santa Maria
  • Krajska nemocnice Liberec a.s. - Kardiocentrum
  • Aalborg Sygehus
  • Aarhus Universitetshospital - Skejby
  • Herz- und Gefässzentrum Bad Bevensen
  • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • Segeberger Kliniken GmbH
  • Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH
  • Universitätsklinikum Bonn
  • MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz
  • Klinikum Coburg GmbH
  • Kardiocentrum Frankfurt an der Klinik Rotes Kreuz
  • Universitätsmedizin Göttingen Georg-August-Universität
  • Ruprecht-Karls-Universität
  • Westpfalz-Klinikum GmbH - Standort I Kaiserslautern
  • Herz Zentrum Bodensee
  • Klinikum Ludwigsburg - Akademisches Lehrkrankenhaus der Universität Heidelberg
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Städtische Kliniken München GmbH - Klinikum Bogenhausen
  • Städtische Kliniken Neuss Lukaskrankenhaus GmbH-Akad.Lehrkrankenhaus d. Heinrich-Heine-Universität
  • Universitätsmedizin Rostock
  • Herz- und Kreislaufzentrum Rotenburg a.d. Fulda GmbH
  • Asklepios Kliniken Schwalm - Eder GmbH - Klinikum Schwalmstadt
  • Heinrich-Braun-Klinikum Zwickau gemeinnützige GmbH
  • Care Institute of Medical Sciences
  • Medanta-The Medicity
  • Barzilai Medical Center Ashkelon
  • Soroka University Medical Center
  • Carmel Medical Center
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • Rabin Medical Center - Beilinson Hospital
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
  • Azienda Complesso Ospedaliero San Filippo Neri - Ospedale San Filippo Neri
  • Hirosaki University School of Medicine & Hospital
  • Kansai Rosai Hospital
  • Kobe University Hospital
  • St. Marianna University School of Medicine Hospital
  • Kinki University Hospital
  • National Cerebral and Cardiovasuclar Center
  • Sapporo Medical Center NTT EC
  • Akita Medical Center
  • Chiba University Hospital
  • Kokura Memorial Hospital
  • Kumamoto University Hospital
  • Kyoto University Hospital
  • Niigata University Medical & Dental Hospital
  • Kitasato University Hospital
  • Institut Jantung Negara - National Heart Institute
  • Medisch Centrum Alkmaar
  • Academisch Medisch Centrum (AMC)
  • Amphia Ziekenhuis - Locatie Molengracht Breda
  • Catharina Ziekenhuis
  • Medisch Spectrum Twente
  • Medisch Centrum Leeuwarden
  • Leids Universitair Medisch Centrum
  • St. Antonius Ziekenhuis
  • Universitair Medisch Centrum Utrecht
  • King Faisal Specialist Hospital & Research Center
  • Prince Salman Heart Centre - King Fahad Medical City
  • University Medical Centre Ljubljana
  • Milpark Hospital
  • Hospital De Cruces
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Complejo Hospitalario Universitario de Vigo (CHUVI) - Hospital del Meixoeiro
  • Universitetssjukhuset i Lund
  • Capio S:t Görans Sjukhus
  • Universitetssjukhuset Örebro
  • Cardio Centro Ticino
  • Sheikh Khalifa Medical Center
  • Royal Bournemouth Hospital
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • King's College Hospital NHS Foundation Trust
  • Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single-chamber detetction

Dual-chamber detection

Arm Description

Patients implanted with a Protecta VR-ICD.

Patients implanted with a Protecta DR-ICD or CRT-D.

Outcomes

Primary Outcome Measures

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 .
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.
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.

Secondary Outcome Measures

Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free

Full Information

First Posted
September 22, 2009
Last Updated
October 5, 2017
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00982397
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachyarrhythmias, Heart Failure, Ventricular Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-chamber detetction
Arm Type
Experimental
Arm Description
Patients implanted with a Protecta VR-ICD.
Arm Title
Dual-chamber detection
Arm Type
Experimental
Arm Description
Patients implanted with a Protecta DR-ICD or CRT-D.
Intervention Type
Device
Intervention Name(s)
Protecta VR-ICD
Intervention Description
Protecta single-chamber implantable cardioverter defibrillators.
Intervention Type
Device
Intervention Name(s)
Protecta DR-ICD or CRT-D
Intervention Description
Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Are Inappropriate Shock Free
Description
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 .
Time Frame
Implant to one year post-implant
Title
Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I)
Description
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.
Time Frame
Implant to one month post-implant
Title
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
Description
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.
Time Frame
At implant
Secondary Outcome Measure Information:
Title
Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free
Time Frame
Implant to one year post-implant

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21669960
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.
Results Reference
background
PubMed Identifier
25637563
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.
Results Reference
result
PubMed Identifier
26988379
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.
Results Reference
result
PubMed Identifier
24665992
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.
Results Reference
result
PubMed Identifier
30478983
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.
Results Reference
derived
PubMed Identifier
29928759
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.
Results Reference
derived

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

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