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

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982397
• Other study ID #: PainFree SST
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: October 5, 2017
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: October 2017
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 defibrillator (CRT-D) will be evaluated.

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 information / eligibility

• Status: Completed
• Enrollment: 2770
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmias
• Tachycardia
• Ventricular Dysfunction

Intervention

Device:
• Protecta VR-ICD
Protecta single-chamber implantable cardioverter defibrillators.
• Protecta DR-ICD or CRT-D
Protecta dual-chamber implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

Locations

Country	Name	City	State
Austria	LKH - Universitätsklinikum Graz	Graz
Austria	Landesklinikum St. Pölten	St. Polten
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Canada	Institut Universitaire de Cardiologieet de Pneumologie de Québec (IUCPQ)	Halifax	Nova Scotia
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	Newmarket Electrophysiology Research Group	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa
Canada	Saint Paul's Hospital (Vancouver BC)	Vancouver	British Columbia
Canada	Royal Jubilee Hospital	Victoria	British Columbia
Colombia	Fundacion Cardioinfantil	Bogota
Colombia	Hospital Cardiovascular del Nino	Bogota
Colombia	Clinica Cardiovascular Santa Maria	Medellin
Czechia	Krajska nemocnice Liberec a.s. - Kardiocentrum	Liberec
Denmark	Aalborg Sygehus	Aalborg
Denmark	Aarhus Universitetshospital - Skejby	Aarhus
Germany	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	Gottingen
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	Munchen
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
India	Care Institute of Medical Sciences	Ahmedabad
India	Medanta-The Medicity	Gurgaon
Israel	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	Petach Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Ospedale classificato ed equiparato Sacro Cuore - Don Calabria	Negrar
Italy	Azienda Complesso Ospedaliero San Filippo Neri - Ospedale San Filippo Neri	Rome
Japan	Akita Medical Center	Akita
Japan	Kansai Rosai Hospital	Amagasak	Hyogo
Japan	Chiba University Hospital	Chiba
Japan	Sapporo Medical Center NTT EC	Chuo-ku	Sapporo
Japan	Hirosaki University School of Medicine & Hospital	Hirosaki	Aomori
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	Kokura Memorial Hospital	Kitakyushu
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Kinki University Hospital	Osakasaya	Osaka
Japan	Kitasato University Hospital	Sagamihara
Japan	National Cerebral and Cardiovasuclar Center	Suita	Osaka
Malaysia	Institut Jantung Negara - National Heart Institute	Kuala Lumpur
Netherlands	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
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh
Saudi Arabia	Prince Salman Heart Centre - King Fahad Medical City	Riyadh
Slovenia	University Medical Centre Ljubljana	Ljubljana
South Africa	Milpark Hospital	Johannesburg
Spain	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
Sweden	Universitetssjukhuset i Lund	Lund
Sweden	Universitetssjukhuset Örebro	Örebro
Sweden	Capio S:t Görans Sjukhus	Stockholm
Switzerland	Cardio Centro Ticino	Lugano
United Arab Emirates	Sheikh Khalifa Medical Center	Abu Dhabi
United Kingdom	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 States	Birmingham Heart Clinic PC	Birmingham	Alabama
United States	Ohio Heart and Vascular	Cincinnati	Ohio
United States	Central Bucks Cardiology	Doylestown	Pennsylvania
United States	Essentia Institute of Rural Health	Duluth	Minnesota
United States	Pee Dee Cardiology	Florence	South Carolina
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Hartford Hospital	Hartford	Connecticut
United States	Hall-Garcia Cardiology Associates	Houston	Texas
United States	Indiana Heart Physicians	Indianapolis	Indiana
United States	University of Florida Health at Jacksonville	Jacksonville	Florida
United States	LA Cardiology Associates	Los Angeles	California
United States	CardioVasular Associates of Mesa	Mesa	Arizona
United States	Arrhythmia Syncope Consultants LLC	Miami	Florida
United States	Columbia St. Mary's Hospital	Milwaukee	Wisconsin
United States	Cardiovascular Research of Northwest Indiana	Munster	Indiana
United States	Cardiology Consultants of Napa Valley	Napa	California
United States	Centennial Heart Cardiovascular Consultants LLC	Nashville	Tennessee
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota
United States	Saint Louis Heart & Vascular PC	Saint Louis	Missouri
United States	Delmarva Heart Research Foundation	Salisbury	Maryland
United States	Cardiology Consultants PA	Spartanburg	South Carolina
United States	Spokane Cardiology	Spokane	Washington
United States	Saint John's Medical Research Inc	Springfield	Missouri
United States	Cardiology PC	Syracuse	New York
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Colombia,  Czechia,  Denmark,  Germany,  India,  Israel,  Italy,  Japan,  Malaysia,  Netherlands,  Saudi Arabia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  United Arab Emirates,  United Kingdom, 

References & Publications (4)

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. — View 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 — View 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 — View Citation

Wollmann CG, Lawo T, Kühlkamp 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free		Implant to one year post-implant