AzTrials
AzTrials

Cardiac Rhythm DisordersPSRNCT01524276

Product Surveillance Registry

An observational study of Cardiac Rhythm Disorders and Urological Disorders, run by Medtronic at 402 sites in 41 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
How many people
100,000 participants
Where
402 sitesin 41 countries
Study dates
Jan 2012to Jan 2040
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects implanted with Medtronic qualifying therapy product.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

402 sites in 41 countries. Contact the study team or a site near you to ask about taking part.

Medtronic Product Surveillance Registry contact

rs.productsurveillanceregistry@medtronic.com

402 sites in 41 countries

United States136 sites, 130 recruiting
  • Study site

    Albany, New York

    Recruiting
  • Study site

    Albuquerque, New Mexico

    Recruiting
  • Study site

    Aliso Viejo, California

    Recruiting
  • Study site

    Allentown, Pennsylvania

    Recruiting
  • Study site

    Ann Arbor, Michigan

    Recruiting
  • Study site

    Aurora, Colorado

    Recruiting
  • Study site

    Austin, Texas

    Recruiting
  • Study site

    Bay City, Michigan

    Recruiting
  • Study site

    Bay Shore, New York

    Recruiting
  • Study site

    Bethlehem, Pennsylvania

    Recruiting
  • Study site

    Birmingham, Alabama

    Recruiting
  • Study site

    Boston, Massachusetts

    Recruiting
  • Study site

    Bradenton, Florida

    Recruiting
  • Study site

    Bremerton, Washington

    Recruiting
  • Study site

    Burlington, Vermont

    Recruiting
  • Study site

    Camden, New Jersey

    Recruiting
  • Study site

    Chandler, Arizona

    Recruiting
  • Study site

    Chapel Hill, North Carolina

    Recruiting
  • Study site

    Charleston, North Carolina

    Recruiting
  • Study site

    Charleston, South Carolina

    Recruiting
  • Study site

    Charlottesville, Virginia

    Recruiting
  • Study site

    Chicago, Illinois

    Recruiting
  • Study site

    Chula Vista, California

    Recruiting
  • Study site

    Clearwater, Florida

    Recruiting
  • Study site

    Cleveland, Ohio

    Recruiting
  • Study site

    Colorado Springs, Colorado

    Recruiting
  • Study site

    Colton, California

    Recruiting
  • Study site

    Columbia, Missouri

    Recruiting
  • Study site

    Columbia, South Carolina

    Recruiting
  • Study site

    Columbus, Ohio

    Recruiting
  • Study site

    Coon Rapids, Minnesota

    Recruiting
  • Study site

    Dallas, Texas

    Recruiting
  • Study site

    Danville, Pennsylvania

    Recruiting
  • Study site

    Darien, Connecticut

    Recruiting
  • Study site

    Davie, Florida

    Recruiting
  • Study site

    Dayton, Ohio

    Recruiting
  • Study site

    Durham, North Carolina

    Recruiting
  • Study site

    Edenton, North Carolina

    Recruiting
  • Study site

    Edgewood, Kentucky

    Recruiting
  • Study site

    Erie, Pennsylvania

    Recruiting
  • Study site

    Evansville, Indiana

    Recruiting
  • Study site

    Fairfax, Virginia

    Recruiting
  • Study site

    Falls Church, Virginia

    Recruiting
  • Study site

    Fort Worth, Texas

    Recruiting
  • Study site

    Fredericksburg, Virginia

    Recruiting
  • Study site

    Gainesville, Georgia

    Active, not recruiting
  • Study site

    Germantown, Tennessee

    Recruiting
  • Study site

    Grapevine, Texas

    Recruiting
  • Study site

    Hartford, Connecticut

    Recruiting
  • Study site

    Holyoke, Massachusetts

    Recruiting
  • Study site

    Houston, Texas

    Recruiting
  • Study site

    Huntington, New York

    Recruiting
  • Study site

    Huntsville, Alabama

    Recruiting
  • Study site

    Hyattsville, Maryland

    Recruiting
  • Study site

    Indianapolis, Indiana

    Recruiting
  • Study site

    Iowa City, Iowa

    Recruiting
  • Study site

    Jackson, Mississippi

    Active, not recruiting
  • Study site

    Jacksonville, Florida

    Recruiting
  • Study site

    Kansas City, Kansas

    Recruiting
  • Study site

    Kansas City, Missouri

    Recruiting
  • Study site

    Kyle, Texas

    Recruiting
  • Study site

    La Jolla, California

    Recruiting
  • Study site

    Lakewood, Colorado

    Recruiting
  • Study site

    Lancaster, Pennsylvania

    Recruiting
  • Study site

    Lansing, Michigan

    Recruiting
  • Study site

    Lebanon, New Hampshire

    Active, not recruiting
  • Study site

    Little Rock, Arkansas

    Recruiting
  • Study site

    Los Angeles, California

    Recruiting
  • Study site

    Louisville, Kentucky

    Recruiting
  • Study site

    Madison, Wisconsin

    Recruiting
  • Study site

    Manhasset, New York

    Recruiting
  • Study site

    Marlton, New Jersey

    Recruiting
  • Study site

    Mechanicsburg, Pennsylvania

    Recruiting
  • Study site

    Memphis, Tennessee

    Recruiting
  • Study site

    Minneapolis, Minnesota

    Recruiting
  • Study site

    Morgantown, West Virginia

    Recruiting
  • Study site

    Morristown, New Jersey

    Recruiting
  • Study site

    Mount Kisco, New York

    Recruiting
  • Study site

    Mount Orab, Ohio

    Recruiting
  • Study site

    Napa, California

    Recruiting
  • Study site

    Naples, Florida

    Recruiting
  • Study site

    Nashville, Tennessee

    Recruiting
  • Study site

    New Haven, Connecticut

    Recruiting
  • Study site

    New Hyde Park, New York

    Recruiting
  • Study site

    New Orleans, Louisiana

    Recruiting
  • Study site

    New York, New York

    Recruiting
  • Study site

    Ocean Township, New Jersey

    Recruiting
  • Study site

    Omaha, Nebraska

    Recruiting
  • Study site

    Orangeburg, South Carolina

    Recruiting
  • Study site

    Panama City, Florida

    Recruiting
  • Study site

    Philadelphia, Pennsylvania

    Recruiting
  • Study site

    Phoenix, Arizona

    Recruiting
  • Study site

    Pinehurst, North Carolina

    Recruiting
  • Study site

    Pittsburgh, Pennsylvania

    Recruiting
  • Study site

    Plano, Texas

    Recruiting
  • Study site

    Port Jefferson, New York

    Recruiting
  • Study site

    Portland, Oregon

    Recruiting
  • Study site

    Poughkeepsie, New York

    Recruiting
  • Study site

    Raleigh, North Carolina

    Recruiting
  • Study site

    Redwood City, California

    Recruiting
  • Study site

    Reno, Nevada

    Active, not recruiting
  • Study site

    Riverhead, New York

    Recruiting
  • Study site

    Robbinsdale, Minnesota

    Recruiting
  • Study site

    Rochester, Minnesota

    Recruiting
  • Study site

    Rochester Hills, Michigan

    Recruiting
  • Study site

    Roslyn, New York

    Active, not recruiting
  • Study site

    Safety Harbor, Florida

    Recruiting
  • Study site

    Saint Cloud, Minnesota

    Active, not recruiting
  • Study site

    Salinas, California

    Recruiting
  • Study site

    Salisbury, Maryland

    Recruiting
  • Study site

    Salt Lake City, Utah

    Recruiting
  • Study site

    San Antonio, Texas

    Recruiting
  • Study site

    San Diego, California

    Recruiting
  • Study site

    Sarasota, Florida

    Recruiting
  • Study site

    Seattle, Washington

    Recruiting
  • Study site

    Sewickley, Pennsylvania

    Recruiting
  • Study site

    Silver Spring, Maryland

    Recruiting
  • Study site

    Sioux Falls, South Dakota

    Recruiting
  • Study site

    Spartanburg, South Carolina

    Recruiting
  • Study site

    Spokane, Washington

    Recruiting
  • Study site

    St Louis, Missouri

    Recruiting
  • Study site

    Stanford, California

    Recruiting
  • Study site

    Staten Island, New York

    Recruiting
  • Study site

    Stony Brook, New York

    Recruiting
  • Study site

    Tampa, Florida

    Recruiting
  • Study site

    Teaneck, New Jersey

    Recruiting
  • Study site

    Temecula, California

    Recruiting
  • Study site

    Torrance, California

    Recruiting
  • Study site

    Tyler, Texas

    Recruiting
  • Study site

    Utica, New York

    Recruiting
  • Study site

    Ventura, California

    Recruiting
  • Study site

    Washington D.C., District of Columbia

    Recruiting
  • Study site

    West Des Moines, Iowa

    Recruiting
  • Study site

    Weston, Florida

    Recruiting
  • Study site

    Wilkes-Barre, Pennsylvania

    Recruiting
  • Study site

    Ypsilanti, Michigan

    Recruiting

Other trials in United States

Japan38 sites, 37 recruiting
  • Study site

    Ageo, Saitama

    Recruiting
  • Study site

    Bunkyō-Ku, Tokyo

    Recruiting
  • Study site

    Chiba

    Recruiting
  • Study site

    Fukui

    Recruiting
  • Study site

    Fukuoka

    Recruiting
  • Study site

    Gifu

    Recruiting
  • Study site

    Hamamatsu

    Recruiting
  • Study site

    Hidaka, Saitama

    Recruiting
  • Study site

    Hirosaki

    Recruiting
  • Study site

    Hiroshima

    Recruiting
  • Study site

    Kagoshima

    Recruiting
  • Study site

    Kamakura

    Recruiting
  • Study site

    Kawasaki

    Recruiting
  • Study site

    Kitakyushu

    Recruiting
  • Study site

    Kofu

    Recruiting
  • Study site

    Koshigaya, Saitama

    Recruiting
  • Study site

    Kumamoto

    Recruiting
  • Study site

    Kyoto

    Recruiting
  • Study site

    Minato-Ku, Tokyo

    Recruiting
  • Study site

    Mitaka

    Recruiting
  • Study site

    Nagoya

    Recruiting
  • Study site

    Niigata

    Recruiting
  • Study site

    Nishinomiya

    Recruiting
  • Study site

    Okayama

    Recruiting
  • Study site

    Osaka

    Recruiting
  • Study site

    Ōsaka-sayama

    Recruiting
  • Study site

    Ōta-ku

    Recruiting
  • Study site

    Sakai, Osaka

    Recruiting
  • Study site

    Sapporo

    Recruiting
  • Study site

    Shinagawa-Ku

    Recruiting
  • Study site

    Shizuoka

    Recruiting
  • Study site

    Suita

    Recruiting
  • Study site

    Tokyo, Tachikawa

    Recruiting
  • Study site

    Tokyo

    Active, not recruiting
  • Study site

    Toyoake

    Recruiting
  • Study site

    Urasoe

    Recruiting
  • Study site

    Yokohama

    Recruiting
  • Study site

    Yonago, Tottori

    Recruiting

Other trials in Japan

France25 sites, 24 recruiting
  • Study site

    Avignon

    Recruiting
  • Study site

    Bordeaux

    Recruiting
  • Study site

    Boulogne-Billancourt

    Recruiting
  • Study site

    Brest

    Recruiting
  • Study site

    Caen

    Recruiting
  • Study site

    Chambray

    Recruiting
  • Study site

    Clermont-Ferrand

    Recruiting
  • Study site

    Créteil

    Recruiting
  • Study site

    Dijon

    Recruiting
  • Study site

    La Rochelle

    Recruiting
  • Study site

    La Tronche

    Recruiting
  • Study site

    Lille

    Recruiting
  • Study site

    Marseille

    Recruiting
  • Study site

    Montpellier

    Recruiting
  • Study site

    Nantes

    Recruiting
  • Study site

    Ollioules

    Active, not recruiting
  • Study site

    Paris

    Recruiting
  • Study site

    Pessac

    Recruiting
  • Study site

    Pringy

    Recruiting
  • Study site

    Rennes

    Recruiting
  • Study site

    Rouen

    Recruiting
  • Study site

    Saint-Priest-en-Jarez

    Recruiting
  • Study site

    Strasbourg

    Recruiting
  • Study site

    Toulouse

    Recruiting
  • Study site

    Villeurbanne

    Recruiting

Other trials in France

Germany25 sites, 23 recruiting
  • Study site

    Aachen

    Recruiting
  • Study site

    Arnsberg

    Recruiting
  • Study site

    Bad Oeynhausen

    Recruiting
  • Study site

    Berlin

    Recruiting
  • Study site

    Berlin

    Active, not recruiting
  • Study site

    Bielefeld

    Recruiting
  • Study site

    Bochum

    Recruiting
  • Study site

    Bremen

    Recruiting
  • Study site

    Cologne

    Recruiting
  • Study site

    Düsseldorf

    Recruiting
  • Study site

    Hagen

    Recruiting
  • Study site

    Halle

    Recruiting
  • Study site

    Hamburg

    Recruiting
  • Study site

    Hanover

    Recruiting
  • Study site

    Heidelberg

    Recruiting
  • Study site

    Jena

    Recruiting
  • Study site

    Karlsruhe

    Recruiting
  • Study site

    Leipzig

    Recruiting
  • Study site

    Lübeck

    Recruiting
  • Study site

    München

    Recruiting
  • Study site

    Münster

    Terminated
  • Study site

    Stuttgart

    Recruiting
  • Study site

    Tübingen

    Recruiting
  • Study site

    Ulm

    Recruiting
  • Study site

    Wiesbaden

    Recruiting

Other trials in Germany

Italy19 sites, 17 recruiting
  • Study site

    Acquaviva delle Fonti

    Recruiting
  • Study site

    Ancona

    Recruiting
  • Study site

    Bari

    Recruiting
  • Study site

    Bergamo

    Recruiting
  • Study site

    Bologna

    Recruiting
  • Study site

    Brescia

    Recruiting
  • Study site

    Caserta

    Recruiting
  • Study site

    Castrovillari

    Recruiting
  • Study site

    Cotignola

    Active, not recruiting
  • Study site

    Lecce

    Recruiting
  • Study site

    Milan

    Recruiting
  • Study site

    Modena

    Recruiting
  • Study site

    Monza

    Recruiting
  • Study site

    Palermo

    Recruiting
  • Study site

    Pisa

    Active, not recruiting
  • Study site

    Roma

    Recruiting
  • Study site

    Rome

    Recruiting
  • Study site

    Taranto

    Recruiting
  • Study site

    Udine

    Recruiting

Other trials in Italy

Spain16 sites, 15 recruiting
  • Study site

    A Coruña

    Recruiting
  • Study site

    Córdoba

    Recruiting
  • Study site

    Elche

    Recruiting
  • Study site

    Girona

    Recruiting
  • Study site

    Granada

    Recruiting
  • Study site

    L'Hospitalet de Llobregat

    Recruiting
  • Study site

    Madrid

    Recruiting
  • Study site

    Málaga

    Recruiting
  • Study site

    Palma de Mallorca

    Recruiting
  • Study site

    Salamanca

    Recruiting
  • Study site

    Santa Cruz de Tenerife

    Recruiting
  • Study site

    Santiago de Compostela

    Recruiting
  • Study site

    Toledo

    Recruiting
  • Study site

    Valencia

    Recruiting
  • Study site

    Valladolid

    Recruiting
  • Study site

    Vitoria-Gasteiz

    Active, not recruiting

Other trials in Spain

United Kingdom16 sites, 13 recruiting
  • Study site

    Barnstaple

    Recruiting
  • Study site

    Birmingham

    Recruiting
  • Study site

    Blackpool

    Recruiting
  • Study site

    Bristol

    Recruiting
  • Study site

    Chelmsford

    Active, not recruiting
  • Study site

    Glasgow

    Active, not recruiting
  • Study site

    Harrow

    Recruiting
  • Study site

    Leicester

    Recruiting
  • Study site

    Liverpool

    Recruiting
  • Study site

    London

    Recruiting
  • Study site

    Manchester

    Recruiting
  • Study site

    Middlesbrough

    Recruiting
  • Study site

    Newcastle upon Tyne

    Recruiting
  • Study site

    Northampton

    Terminated
  • Study site

    Sheffield

    Recruiting
  • Study site

    Southampton

    Recruiting

Other trials in United Kingdom

China15 sites, 15 recruiting
  • Study site

    Beijing

    Recruiting
  • Study site

    Chengdu, Sichuan

    Recruiting
  • Study site

    Chengdu

    Recruiting
  • Study site

    Dalian

    Recruiting
  • Study site

    Guangzhou

    Recruiting
  • Study site

    Hangzhou

    Recruiting
  • Study site

    Harbin

    Recruiting
  • Study site

    Hefei

    Recruiting
  • Study site

    Kunming

    Recruiting
  • Study site

    Nanchang

    Recruiting
  • Study site

    Nanjing

    Recruiting
  • Study site

    Nanning, Guangxi

    Recruiting
  • Study site

    Shanghai

    Recruiting
  • Study site

    Suzhou

    Recruiting
  • Study site

    Ürümqi

    Recruiting

Other trials in China

South Korea14 sites, 14 recruiting
  • Study site

    Busan

    Recruiting
  • Study site

    Changwon

    Recruiting
  • Study site

    Cheongju-si

    Recruiting
  • Study site

    Daegu

    Recruiting
  • Study site

    Daejeon

    Recruiting
  • Study site

    Gangneung

    Recruiting
  • Study site

    Gwangju

    Recruiting
  • Study site

    Gyeonggi-do

    Recruiting
  • Study site

    Incheon

    Recruiting
  • Study site

    Jeonju

    Recruiting
  • Study site

    Seongnam-si

    Recruiting
  • Study site

    Seoul

    Recruiting
  • Study site

    Suwon

    Recruiting
  • Study site

    Yangsan, Gyeongsangnam-do

    Recruiting

Other trials in South Korea

Netherlands11 sites, 11 recruiting
  • Study site

    Amsterdam

    Recruiting
  • Study site

    Doetinchem

    Recruiting
  • Study site

    Eindhoven

    Recruiting
  • Study site

    Enschede

    Recruiting
  • Study site

    Groningen

    Recruiting
  • Study site

    Hengelo

    Recruiting
  • Study site

    Leiden

    Recruiting
  • Study site

    Maastricht

    Recruiting
  • Study site

    Nieuwegein

    Recruiting
  • Study site

    Rotterdam

    Recruiting
  • Study site

    The Hague

    Recruiting

Other trials in Netherlands

Belgium10 sites, 9 recruiting
  • Study site

    Aalst

    Recruiting
  • Study site

    Bruges

    Recruiting
  • Study site

    Brussels

    Recruiting
  • Study site

    Edegem

    Recruiting
  • Study site

    Genk, Belgium

    Active, not recruiting
  • Study site

    Ghent

    Recruiting
  • Study site

    Leuven

    Recruiting
  • Study site

    Liège

    Recruiting
  • Study site

    Roeselare

    Recruiting
  • Study site

    Sint-Niklaas

    Recruiting

Other trials in Belgium

Switzerland9 sites, 9 recruiting
  • Study site

    Basel

    Recruiting
  • Study site

    Bern

    Recruiting
  • Study site

    Fribourg

    Recruiting
  • Study site

    Geneva

    Recruiting
  • Study site

    Lausanne

    Recruiting
  • Study site

    Lugano

    Recruiting
  • Study site

    Meyrin

    Recruiting
  • Study site

    Morges

    Recruiting
  • Study site

    Zurich

    Recruiting

Other trials in Switzerland

India8 sites, 8 recruiting
  • Study site

    Bangalore

    Recruiting
  • Study site

    Bengaluru

    Recruiting
  • Study site

    Chennai

    Recruiting
  • Study site

    Gūrgaon

    Recruiting
  • Study site

    Hyderabad, Telangana

    Recruiting
  • Study site

    Jaipur, Rajasthan

    Recruiting
  • Study site

    Kochi

    Recruiting
  • Study site

    New Delhi

    Recruiting

Other trials in India

Canada6 sites, 6 recruiting
  • Study site

    Calgary, Alberta

    Recruiting
  • Study site

    Kingston, Ontario

    Recruiting
  • Study site

    Montreal, Quebec

    Recruiting
  • Study site

    Québec, Quebec

    Recruiting
  • Study site

    Québec

    Recruiting
  • Study site

    Toronto

    Recruiting

Other trials in Canada

Portugal5 sites, 5 recruiting
  • Study site

    Carnaxide

    Recruiting
  • Study site

    Creixomil

    Recruiting
  • Study site

    Lisbon

    Recruiting
  • Study site

    Porto

    Recruiting
  • Study site

    Santarém

    Recruiting

Other trials in Portugal

Australia4 sites, 4 recruiting
  • Study site

    Chermside

    Recruiting
  • Study site

    Murdoch

    Recruiting
  • Study site

    Southport

    Recruiting
  • Study site

    Westmead, New South Wales

    Recruiting

Other trials in Australia

Colombia4 sites, 4 recruiting
  • Study site

    Cartagena

    Recruiting
  • Study site

    Medellín

    Recruiting
  • Study site

    Pereira

    Recruiting
  • Study site

    Rionegro

    Recruiting

Other trials in Colombia

Denmark4 sites, 4 recruiting
  • Study site

    Copenhagen

    Recruiting
  • Study site

    Hellerup

    Recruiting
  • Study site

    Hillerød

    Recruiting
  • Study site

    Odense

    Recruiting

Other trials in Denmark

Israel4 sites, 2 recruiting
  • Study site

    Ashkelon

    Active, not recruiting
  • Study site

    Beersheba

    Recruiting
  • Study site

    Jerusalem

    Terminated
  • Study site

    Ramat Gan

    Recruiting

Other trials in Israel

Greece3 sites, 3 recruiting
  • Study site

    Athens

    Recruiting
  • Study site

    Marousi

    Recruiting
  • Study site

    Thessaloniki

    Recruiting

Other trials in Greece

Norway3 sites, 2 recruiting
  • Study site

    Bergen

    Recruiting
  • Study site

    Lorenskog

    Active, not recruiting
  • Study site

    Trondheim

    Recruiting

Other trials in Norway

Poland3 sites, 3 recruiting
  • Study site

    Poznan

    Recruiting
  • Study site

    Warsaw

    Recruiting
  • Study site

    Zabrze

    Recruiting

Other trials in Poland

Austria2 sites, 2 recruiting
  • Study site

    Innsbruck

    Recruiting
  • Study site

    Linz

    Recruiting

Other trials in Austria

Finland2 sites, 2 recruiting
  • Study site

    Helsinki

    Recruiting
  • Study site

    Tampere

    Recruiting

Other trials in Finland

Puerto Rico2 sites, 2 recruiting
  • Study site

    Aibonito

    Recruiting
  • Study site

    Rio Piedras

    Recruiting

Other trials in Puerto Rico

Saudi Arabia2 sites, 1 recruiting
  • Study site

    Jeddah

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About this study

Official title: Medtronic Product Surveillance Registry

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.

Medical subject headings
Urologic Diseases, Nervous System Diseases, Cardiovascular Diseases, Digestive System Diseases, Intracranial Aneurysm, Renal Insufficiency, Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Effectiveness of Market Released products

    Measured: Every 6-12 months (Therapy-dependent)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2040 (estimated)
  4. Study completionJan 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01524276
Sponsor's protocol ID
PSR
Acronym
PSR
Status last verified
Dec 2025
First submitted
30 Jan 2012
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Wu V, Makary MS, Tarter W, Elsaadany A, Shrestha P. Real-World Safety and Performance of Nylon and PGLA Fibered Detachable Coils in Peripheral Embolization: A Prospective Multicenter Registry. J Vasc Interv Radiol. 2026 Jul 14:108959. doi: 10.1016/j.jvir.2026.108959. Online ahead of print.

    PubMed 42448174
  • Quyn A, Navarro A, Caldonazo T, Findlay JM, Doenst T, Anderson M, Gong X, Botman JMJ. Real-World Performance of the Veriset Hemostatic Patch: A Multicenter Study of Adjunctive Hemostasis. Med Devices (Auckl). 2026 May 29;19:595863. doi: 10.2147/MDER.S595863. eCollection 2026.

    PubMed 42239929
  • Goya M, Park SJ, Ando K, Holbrook R, Iskandar R, Jacobsen L, Mozingo JD, Joung B; SPARK Registry Investigators. Safety and efficacy of an intrinsic antitachycardia pacing algorithm in patients from Japan and South Korea: results from a cardiac device registry in the Asia Pacific region. J Med Econ. 2025 Dec;28(1):1307-1318. doi: 10.1080/13696998.2025.2543213. Epub 2025 Aug 13.

    PubMed 40758483
  • Patel D, Rao A, Friedman PA, Deshmukh AJ, Lande J, Murphy JA, Brown ML, Lexcen DR, Wilkoff BL. New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation. J Cardiovasc Electrophysiol. 2023 Feb;34(2):438-444. doi: 10.1111/jce.15790. Epub 2022 Dec 30.

    PubMed 36579406
  • 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.

    PubMed 35925831
  • 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.

    PubMed 32763431
  • 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.

    PubMed 32009263
  • 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.

    PubMed 31567325

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Rhythm Disorders and Urological Disorders, run by Medtronic at 402 sites in 41 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 402 sites in United States, Japan, France, Germany, Italy and 36 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medtronic Product Surveillance Registry (rs.productsurveillanceregistry@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Effectiveness of Market Released products (time frame: Every 6-12 months (Therapy-dependent)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01524276, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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