Safety and Clinical Performance of the Protecta ICD and CRT-D
- Conditions
- Ventricular DysfunctionHeart FailureTachyarrhythmias
- Interventions
- Device: Protecta DR-ICD or CRT-DDevice: Protecta VR-ICD
- Registration Number
- NCT00982397
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2770
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dual-chamber detection Protecta DR-ICD or CRT-D Patients implanted with a Protecta DR-ICD or CRT-D. Single-chamber detetction Protecta VR-ICD Patients implanted with a Protecta VR-ICD.
- Primary Outcome Measures
Name Time Method Percentage of Subjects Who Are Inappropriate Shock Free 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 .
Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I) 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.
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 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.
- Secondary Outcome Measures
Name Time Method Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free Implant to one year post-implant
Trial Locations
- Locations (122)
LKH - Universitätsklinikum Graz
🇦🇹Graz, Austria
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
Hospital Cardiovascular del Nino
🇨🇴Bogota, Colombia
Saint Paul's Hospital (Vancouver BC)
🇨🇦Vancouver, British Columbia, Canada
Fundacion Cardioinfantil
🇨🇴Bogota, Colombia
Medanta-The Medicity
🇮🇳Gurgaon, India
Prince Salman Heart Centre - King Fahad Medical City
🇸🇦Riyadh, Saudi Arabia
Sheikh Khalifa Medical Center
🇦🇪Abu Dhabi, United Arab Emirates
CardioVasular Associates of Mesa
🇺🇸Mesa, Arizona, United States
Mercy Hospital Fort Smith
🇺🇸Fort Smith, Arkansas, United States
LA Cardiology Associates
🇺🇸Los Angeles, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Essentia Institute of Rural Health
🇺🇸Duluth, Minnesota, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Saint John's Medical Research Inc
🇺🇸Springfield, Missouri, United States
Cardiology PC
🇺🇸Syracuse, New York, United States
Pinehurst Medical Clinic
🇺🇸Pinehurst, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Newmarket Electrophysiology Research Group
🇨🇦Newmarket, Ontario, Canada
Cardiology Consultants of Napa Valley
🇺🇸Napa, California, United States
University of Florida Health at Jacksonville
🇺🇸Jacksonville, Florida, United States
Cardiovascular Research of Northwest Indiana
🇺🇸Munster, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Saint Louis Heart & Vascular PC
🇺🇸Saint Louis, Missouri, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Central Bucks Cardiology
🇺🇸Doylestown, Pennsylvania, United States
Pee Dee Cardiology
🇺🇸Florence, South Carolina, United States
Cardiology Consultants PA
🇺🇸Spartanburg, South Carolina, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
Hall-Garcia Cardiology Associates
🇺🇸Houston, Texas, United States
Columbia St. Mary's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Spokane Cardiology
🇺🇸Spokane, Washington, United States
Landesklinikum St. Pölten
🇦🇹St. Polten, Austria
Institut Universitaire de Cardiologieet de Pneumologie de Québec (IUCPQ)
🇨🇦Halifax, Nova Scotia, Canada
Queen's University & Kingston General Hospital
🇨🇦Kingston, Canada
Kelowna Arrhythmia Research
🇨🇦Kelowna, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Canada
London Health Sciences Centre - University Campus
🇨🇦London, Canada
Montreal Heart Institute
🇨🇦Montreal, Canada
Aalborg Sygehus
🇩🇰Aalborg, Denmark
Clinica Cardiovascular Santa Maria
🇨🇴Medellin, Colombia
Krajska nemocnice Liberec a.s. - Kardiocentrum
🇨🇿Liberec, Czechia
Aarhus Universitetshospital - Skejby
🇩🇰Aarhus, Denmark
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
🇩🇪Bad Oeynhausen, Germany
Herz- und Gefässzentrum Bad Bevensen
🇩🇪Bad Bevensen, 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
🇩🇪Gottingen, Germany
Ruprecht-Karls-Universität
🇩🇪Heidelberg, Germany
Westpfalz-Klinikum GmbH - Standort I Kaiserslautern
🇩🇪Kaiserslautern, Germany
Klinikum Ludwigsburg - Akademisches Lehrkrankenhaus der Universität Heidelberg
🇩🇪Ludwigsburg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Städtische Kliniken München GmbH - Klinikum Bogenhausen
🇩🇪Munchen, Germany
Städtische Kliniken Neuss Lukaskrankenhaus GmbH-Akad.Lehrkrankenhaus d. Heinrich-Heine-Universität
🇩🇪Neuss, Germany
Asklepios Kliniken Schwalm - Eder GmbH - Klinikum Schwalmstadt
🇩🇪Schwalmstadt, Germany
Universitätsmedizin Rostock
🇩🇪Rostock, Germany
Herz- und Kreislaufzentrum Rotenburg a.d. Fulda GmbH
🇩🇪Rotenburg a.d. Fulda, Germany
Care Institute of Medical Sciences
🇮🇳Ahmedabad, India
Heinrich-Braun-Klinikum Zwickau gemeinnützige GmbH
🇩🇪Zwickau, Germany
Soroka University Medical Center
🇮🇱Be'er Sheba, Israel
Carmel Medical Center
🇮🇱Haifa, Israel
Barzilai Medical Center Ashkelon
🇮🇱Ashkelon, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center - Beilinson Hospital
🇮🇱Petach Tikva, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, 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, Hyogo, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Sapporo Medical Center NTT EC
🇯🇵Chuo-ku, Sapporo, Japan
Akita Medical Center
🇯🇵Akita, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Kitasato University Hospital
🇯🇵Sagamihara, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
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
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
King Faisal Specialist Hospital & Research Center
🇸🇦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
Capio S:t Görans Sjukhus
🇸🇪Stockholm, Sweden
Cardio Centro Ticino
🇨ðŸ‡Lugano, Switzerland
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
Delmarva Heart Research Foundation
🇺🇸Salisbury, Maryland, United States
Arrhythmia Syncope Consultants LLC
🇺🇸Miami, Florida, United States
Indiana Heart Physicians
🇺🇸Indianapolis, Indiana, United States
Academisch Medisch Centrum (AMC)
🇳🇱Amsterdam, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Herz Zentrum Bodensee
🇩🇪Konstanz, Germany
National Cerebral and Cardiovasuclar Center
🇯🇵Suita, Osaka, Japan
Kinki University Hospital
🇯🇵Osakasaya, Osaka, Japan
Birmingham Heart Clinic PC
🇺🇸Birmingham, Alabama, United States
Ohio Heart and Vascular
🇺🇸Cincinnati, Ohio, United States
Centennial Heart Cardiovascular Consultants LLC
🇺🇸Nashville, Tennessee, United States
Universitetssjukhuset Örebro
🇸🇪Örebro, Sweden
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Canada