Clinical trial NCT01524276: Product Surveillance Registry
Official title: Medtronic Product Surveillance Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Rhythm Disorders
Urological Disorders
Neurological Disorders
Cardiovascular Disorders
Digestive Disorders
Intracranial Aneurysm
Mechanical Circulatory Support
Respiratory Therapy
Aortic, Peripheral Vascular and Venous Disorders
Minimally Invasive Surgical Procedures
Diagnostic Techniques and Procedures
Surgical Procedures, Operative
Renal Insufficiency
Neurovascular
Coronary Artery Disease
Ear, Nose and Throat Disorder
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects implanted with Medtronic qualifying therapy product.

Brief summary: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.


Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

* Patient who is, or will be, inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Primary outcomes:
measure: Safety and Effectiveness of Market Released products
timeFrame: Every 6-12 months (Therapy-dependent)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Aliso Viejo
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Colton
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Napa
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Darien
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Davie
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Gainesville
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: West Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Hyattsville
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Holyoke
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Bay City
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Rochester Hills
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Coon Rapids
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Robbinsdale
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Saint Cloud
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Camden
country: United States
state: New Jersey
city: Marlton
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Ocean Township
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Bay Shore
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: Mount Kisco
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Riverhead
country: United States
state: New York
city: Roslyn
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charleston
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Pinehurst
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Mount Orab
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Mechanicsburg
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Germantown
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Kyle
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Fredericksburg
country: United States
state: Virginia
city: Bremerton
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Westmead
country: Australia
state: New South Wales
city: Chermside
country: Australia
city: Murdoch
country: Australia
city: Southport
country: Australia
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Aalst
country: Belgium
city: Brugge
country: Belgium
city: Brussel
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Sint-Niklaas
country: Belgium
city: São Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Kingston
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
city: Quebec
country: Canada
city: Toronto
country: Canada
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Chengdu
country: China
city: Dalian
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Kunming
country: China
city: Nanchang
country: China
city: Shanghai
country: China
city: Suzhou
country: China
city: Medellin
country: Colombia
city: Pereira
country: Colombia
city: Rionegro
country: Colombia
city: Praha
country: Czechia
city: Hellerup
country: Denmark
city: Hillerød
country: Denmark
city: Kobenhavn
country: Denmark
city: Odense
country: Denmark
city: Helsinki
country: Finland
city: Tampere
country: Finland
city: Avignon
country: France
city: Bordeaux
country: France
city: Boulogne-Billancourt
country: France
city: Brest Cedex
country: France
city: Caen
country: France
city: Chambray
country: France
city: Clermont Ferrand
country: France
city: Créteil
country: France
city: Dijon
country: France
city: La Rochelle
country: France
city: La Tronche
country: France
city: Lille Cedex
country: France
city: Marseille Cedex 5
country: France
city: Montpellier Cedex 5
country: France
city: Nantes
country: France
city: Ollioules
country: France
city: Paris
country: France
city: Pessac
country: France
city: Pringy
country: France
city: Rennes
country: France
city: Saint-Priest-en-Jarez
country: France
city: Strasbourg
country: France
city: Toulouse Cedex 9
country: France
city: Villeurbanne
country: France
city: Aachen
country: Germany
city: Arnsberg
country: Germany
city: Bad Oeynhausen
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bremen
country: Germany
city: Düsseldorf
country: Germany
city: Freiburg
country: Germany
city: Hagen
country: Germany
city: Halle (Saale)
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Lübeck
country: Germany
city: Munster
country: Germany
city: München
country: Germany
city: Stuttgart
country: Germany
city: Tubingen
country: Germany
city: Ulm
country: Germany
city: Wiesbaden
country: Germany
city: Athens
country: Greece
city: Maroúsi
country: Greece
city: Thessaloníki
country: Greece
city: Hong Kong
country: Hong Kong
city: Budapest
country: Hungary
city: Hyderabad
country: India
state: Telangana
city: Bangalore
country: India
city: Bengaluru
country: India
city: Chennai
country: India
city: Gurugram
country: India
city: New Delhi
country: India
city: Galway
country: Ireland
city: Ashkelon
country: Israel
city: Be'er Sheva
country: Israel
city: Jerusalem
country: Israel
city: Ramat Gan
country: Israel
city: Acquaviva Delle Fonti
country: Italy
city: Ancona
country: Italy
city: Bari
country: Italy
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Caserta
country: Italy
city: Castrovillari
country: Italy
city: Cotignola
country: Italy
city: Lecce
country: Italy
city: Milano
country: Italy
city: Monza
country: Italy
city: Palermo
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Rome
country: Italy
city: Taranto
country: Italy
city: Udine
country: Italy
city: Sakai
country: Japan
state: Osaka
city: Ageo
country: Japan
state: Saitama
city: Hidaka
country: Japan
state: Saitama
city: Koshigaya
country: Japan
state: Saitama
city: Tokyo
country: Japan
state: Tachikawa
city: Bunkyō-Ku
country: Japan
state: Tokyo
city: Minato-Ku
country: Japan
state: Tokyo
city: Yonago
country: Japan
state: Tottori
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hirosaki
country: Japan
city: Hiroshima City
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kamakura
country: Japan
city: Kawasaki
country: Japan
city: Kitakyushu
country: Japan
city: Kofu
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Mitaka
country: Japan
city: Nagoya
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Sapporo
country: Japan
city: Shinagawa-Ku
country: Japan
city: Shizuoka
country: Japan
city: Suita
country: Japan
city: Tokyo
country: Japan
city: Toyoake
country: Japan
city: Urasoe
country: Japan
city: Yokohama
country: Japan
city: Ōsaka-sayama
country: Japan
city: Yangsan
country: Korea, Republic of
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
city: Changwon
country: Korea, Republic of
city: Cheongju-si
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gangneung
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Seongnam-si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon-si
country: Korea, Republic of
city: Kuwait
country: Kuwait
city: Kuala Lumpur
country: Malaysia
city: Ciudad de mexico
country: Mexico
city: Breda
country: Netherlands
city: Den Haag
country: Netherlands
city: Doetinchem
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Groningen
country: Netherlands
city: Heerlen
country: Netherlands
city: Hengelo
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Christchurch
country: New Zealand
city: Bergen
country: Norway
city: Lorenskog
country: Norway
city: Trondheim
country: Norway
city: Panama
country: Panama
city: Poznań
country: Poland
city: Warszawa
country: Poland
city: Zabrze
country: Poland
city: Carnaxide
country: Portugal
city: Creixomil
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Santarém
country: Portugal
city: Aibonito
country: Puerto Rico
city: Rio Piedras
country: Puerto Rico
city: Jeddah
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
city: Belgrade
country: Serbia
city: Bratislava
country: Slovakia
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: L'Hospitalet De Llobregat
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Palma De Mallorca
country: Spain
city: Salamanca
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Santiago De Compostela
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Vitoria-Gasteiz
country: Spain
city: Skövde
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Fribourg
country: Switzerland
city: Geneve
country: Switzerland
city: Lausanne
country: Switzerland
city: Lugano
country: Switzerland
city: Morges
country: Switzerland
city: Zürich
country: Switzerland
city: Taichung
country: Taiwan
city: Barnstaple
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Bristol
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrow
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Northampton
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
References:
citation: Qin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4.
citation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.
citation: Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28.
citation: Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425.