Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products (PPR)

Medtronic CRDM Product Performance Report

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Bradycardia; Arrhythmia; Sinus Tachycardia
• Intervention / Treatment: Device: Device

Detailed Description

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Medtronic CRM Clinical Trials; Email: medtroniccrmtrials@medtronic.com

Study Locations

• Australia
  • Chermside, Australia
    • Recruiting
  • Douglas, Australia
    • Terminated
  • Murdoch, Australia
    • Recruiting
  • Southport, Australia
    • Recruiting
• Austria
  • Graz, Austria
    • Recruiting
  • Linz, Austria
    • Recruiting
• Belgium
  • Brugge, Belgium
    • Recruiting
  • Brussel, Belgium
    • Recruiting
  • Edegem, Belgium
    • Active, not recruiting
  • Leuven, Belgium
    • Recruiting
  • Liège, Belgium
    • Recruiting
  • Yvoir, Belgium
    • Terminated
• Canada
  • Calgary, Canada
    • Recruiting
  • Kingston, Canada
    • Recruiting
  • Montreal, Canada
    • Recruiting
  • Québec, Canada
    • Recruiting
• China
  • Beijing, China
    • Recruiting
  • Changsha, China
    • Recruiting
  • Dalian, China
    • Recruiting
  • Fuzhou, China
    • Recruiting
  • Kunming, China
    • Recruiting
  • Nanchang, China
    • Recruiting
  • Shanghai, China
    • Recruiting
  • Shantou, China
    • Recruiting
  • Suzhou, China
    • Recruiting
  • Taiyuan, China
    • Recruiting
  • Tianjin, China
    • Recruiting
• Czechia
  • Praha, Czechia
    • Active, not recruiting
• Denmark
  • Hellerup, Denmark
    • Active, not recruiting
  • Hillerød, Denmark
    • Active, not recruiting
  • Odense, Denmark
    • Recruiting
  • Århus, Denmark
    • Active, not recruiting
• Finland
  • Helsinki, Finland
    • Recruiting
• France
  • Avignon, France
    • Recruiting
  • Bayonne, France
    • Active, not recruiting
  • Brest, France
    • Recruiting
  • Caen, France
    • Recruiting
  • Chambray-lès-Tours, France
    • Active, not recruiting
  • Clermont-Ferrand, France
    • Recruiting
  • Dijon, France
    • Recruiting
  • La Rochelle, France
    • Recruiting
  • La Tronche, France
    • Active, not recruiting
  • Lille, France
    • Active, not recruiting
  • Montpellier, France
    • Recruiting
  • Nantes, France
    • Recruiting
  • Neuilly-sur-Seine, France
    • Active, not recruiting
  • Paris, France
    • Recruiting
  • Pessac, France
    • Active, not recruiting
  • Pringy, France
    • Recruiting
  • Rennes, France
    • Active, not recruiting
  • Saint-Priest-en-Jarez, France
    • Active, not recruiting
  • Strasbourg, France
    • Active, not recruiting
  • Toulouse, France
    • Active, not recruiting
  • Vandoeuvre les Nancy, France
    • Active, not recruiting
  • Villeurbanne, France
    • Active, not recruiting
• Germany
  • Aachen, Germany
    • Recruiting
  • Bad Oeynhausen, Germany
    • Recruiting
  • Bremen, Germany
    • Recruiting
  • Dresden, Germany
    • Terminated
  • Düsseldorf, Germany
    • Recruiting
  • Essen, Germany
    • Recruiting
  • Hamburg, Germany
    • Active, not recruiting
  • Hannover, Germany
    • Recruiting
  • Heidelberg, Germany
    • Terminated
  • Homburg, Germany
    • Recruiting
  • Jena, Germany
    • Active, not recruiting
  • Köln, Germany
    • Recruiting
  • München, Germany
    • Recruiting
  • Münster, Germany
    • Active, not recruiting
  • Tübingen, Germany
    • Terminated
  • Ulm, Germany
    • Recruiting
• Greece
  • Athens, Greece
    • Recruiting
  • Marousi, Greece
    • Active, not recruiting
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
• Hungary
  • Budapest, Hungary
    • Recruiting
• Iceland
  • Reykjavik, Iceland
    • Terminated
• Israel
  • Ashkelon, Israel
    • Recruiting
  • Jerusalem, Israel
    • Recruiting
  • Ramat Gan, Israel
    • Recruiting
• Italy
  • Bari, Italy
    • Active, not recruiting
  • Bologna, Italy
    • Active, not recruiting
  • Brescia, Italy
    • Active, not recruiting
  • Castrovillari, Italy
    • Recruiting
  • Cotignola, Italy
    • Active, not recruiting
  • Lecce, Italy
    • Recruiting
  • Milano, Italy
    • Recruiting
  • Pisa, Italy
    • Active, not recruiting
  • Taranto, Italy
    • Recruiting
  • Udine, Italy
    • Recruiting
• Japan
  • Ageo, Japan
    • Recruiting
  • Gifu, Japan
    • Recruiting
  • Hidaka, Japan
    • Active, not recruiting
  • Hiroshima City, Japan
    • Recruiting
  • Kagoshima, Japan
    • Recruiting
  • Kamakura, Japan
    • Recruiting
  • Kawasaki, Japan
    • Recruiting
  • Kitakyushu, Japan
    • Recruiting
  • Koshigaya, Japan
    • Recruiting
  • Kyoto, Japan
    • Recruiting
  • Mitaka, Japan
    • Recruiting
  • Nagoya, Japan
    • Active, not recruiting
  • Niigata, Japan
    • Recruiting
  • Okayama, Japan
    • Recruiting
  • Sapporo, Japan
    • Recruiting
  • Shinagawa-Ku, Japan
    • Recruiting
  • Shizuoka, Japan
    • Recruiting
  • Suita, Japan
    • Recruiting
  • Tokyo, Japan
    • Recruiting
  • Toyoake, Japan
    • Recruiting
  • Urasoe, Japan
    • Recruiting
  • Yamagata, Japan
    • Terminated
  • Yokohama, Japan
    • Recruiting
  • Ōsaka-sayama, Japan
    • Recruiting
• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Recruiting
  • Daejeon, Korea, Republic of
    • Recruiting
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
  • Seoul, Korea, Republic of
    • Recruiting
  • Suwon-si, Korea, Republic of
    • Recruiting
• Kuwait
  • Hadiya, Kuwait
    • Terminated
• Malaysia
  • Kuala Lumpur, Malaysia
    • Recruiting
• Netherlands
  • Amsterdam, Netherlands
    • Active, not recruiting
  • Breda, Netherlands
    • Active, not recruiting
  • Den Haag, Netherlands
    • Active, not recruiting
  • Eindhoven, Netherlands
    • Active, not recruiting
  • Enschede, Netherlands
    • Active, not recruiting
  • Groningen, Netherlands
    • Active, not recruiting
  • Leiden, Netherlands
    • Active, not recruiting
  • Maastricht, Netherlands
    • Recruiting
  • Nieuwegein, Netherlands
    • Recruiting
  • Rotterdam, Netherlands
    • Recruiting
• New Zealand
  • Christchurch, New Zealand
    • Recruiting
• Norway
  • Bergen, Norway
    • Recruiting
  • Oslo, Norway
    • Recruiting
  • Trondheim, Norway
    • Recruiting
• Poland
  • Poznań, Poland
    • Active, not recruiting
  • Warsaw, Poland
    • Recruiting
  • Zabrze, Poland
    • Active, not recruiting
• Portugal
  • Carnaxide, Portugal
    • Recruiting
  • Creixomil, Portugal
    • Recruiting
  • Lisboa, Portugal
    • Active, not recruiting
  • Porto, Portugal
    • Recruiting
  • Santarém, Portugal
    • Recruiting
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Active, not recruiting
  • Riyadh, Saudi Arabia
    • Active, not recruiting
• Serbia
  • Belgrade, Serbia
    • Recruiting
• Slovakia
  • Bratislava, Slovakia
    • Recruiting
  • Košice, Slovakia
    • Terminated
• Slovenia
  • Ljubljana, Slovenia
    • Terminated
• Spain
  • A Coruña, Spain
    • Recruiting
  • Barcelona, Spain
    • Active, not recruiting
  • Córdoba, Spain
    • Recruiting
  • Granada, Spain
    • Recruiting
  • Madrid, Spain
    • Recruiting
  • Palma De Mallorca, Spain
    • Recruiting
  • Salamanca, Spain
    • Recruiting
  • Santa Cruz De Tenerife, Spain
    • Recruiting
  • Santiago de Compostela, Spain
    • Recruiting
  • Toledo, Spain
    • Recruiting
  • Valladolid, Spain
    • Recruiting
  • Vitoria-Gasteiz, Spain
    • Active, not recruiting
• Sweden
  • Göteborg, Sweden
    • Recruiting
  • Lund, Sweden
    • Recruiting
  • Skövde, Sweden
    • Recruiting
  • Uppsala, Sweden
    • Active, not recruiting
• Switzerland
  • Basel, Switzerland
    • Recruiting
  • Bern, Switzerland
    • Recruiting
  • Fribourg, Switzerland
    • Active, not recruiting
  • Geneva, Switzerland
    • Recruiting
  • Lausanne, Switzerland
    • Active, not recruiting
  • Lugano, Switzerland
    • Active, not recruiting
  • Zürich, Switzerland
    • Recruiting
• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
  • Blackpool, United Kingdom
    • Recruiting
  • Bristol, United Kingdom
    • Recruiting
  • Leeds, United Kingdom
    • Recruiting
  • Leicester, United Kingdom
    • Recruiting
  • Liverpool, United Kingdom
    • Recruiting
  • London, United Kingdom
    • Recruiting
  • Manchester, United Kingdom
    • Recruiting
  • Middlesbrough, United Kingdom
    • Recruiting
  • Northampton, United Kingdom
    • Recruiting
  • Nottingham, United Kingdom
    • Terminated
  • Sheffield, United Kingdom
    • Recruiting
  • Southampton, United Kingdom
    • Recruiting
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Recruiting
  • Alaska
    • Anchorage, Alaska, United States
      • Recruiting
  • Arizona
    • Chandler, Arizona, United States
      • Recruiting
  • Arkansas
    • Jonesboro, Arkansas, United States
      • Recruiting
    • Little Rock, Arkansas, United States
      • Recruiting
  • California
    • Bakersfield, California, United States
      • Recruiting
    • Chula Vista, California, United States
      • Recruiting
    • Los Angeles, California, United States
      • Terminated
    • Palm Springs, California, United States
      • Terminated
    • Rancho Mirage, California, United States
      • Recruiting
    • Redwood City, California, United States
      • Recruiting
    • Salinas, California, United States
      • Recruiting
    • San Diego, California, United States
      • Recruiting
    • Stanford, California, United States
      • Recruiting
    • Torrance, California, United States
      • Recruiting
    • Van Nuys, California, United States
      • Recruiting
    • Ventura, California, United States
      • Recruiting
  • Colorado
    • Centennial, Colorado, United States
      • Recruiting
    • Colorado Springs, Colorado, United States
      • Recruiting
    • Denver, Colorado, United States
      • Terminated
    • Lakewood, Colorado, United States
      • Recruiting
  • Connecticut
    • Hartford, Connecticut, United States
      • Recruiting
    • New Haven, Connecticut, United States
      • Recruiting
  • District of Columbia
    • Washington, District of Columbia, United States
      • Recruiting
  • Florida
    • Bradenton, Florida, United States
      • Terminated
    • Clearwater, Florida, United States
      • Recruiting
    • Hollywood, Florida, United States
      • Recruiting
    • Jacksonville, Florida, United States
      • Recruiting
    • Panama City, Florida, United States
      • Recruiting
    • Safety Harbor, Florida, United States
      • Recruiting
    • Sarasota, Florida, United States
      • Recruiting
  • Georgia
    • Atlanta, Georgia, United States
      • Recruiting
    • Marietta, Georgia, United States
      • Active, not recruiting
  • Indiana
    • Evansville, Indiana, United States
      • Recruiting
    • Indianapolis, Indiana, United States
      • Recruiting
  • Iowa
    • West Des Moines, Iowa, United States
      • Recruiting
  • Kansas
    • Kansas City, Kansas, United States
      • Recruiting
  • Kentucky
    • Edgewood, Kentucky, United States
      • Recruiting
    • Louisville, Kentucky, United States
      • Recruiting
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Recruiting
    • Shreveport, Louisiana, United States
      • Terminated
  • Maryland
    • Baltimore, Maryland, United States
      • Terminated
    • Bethesda, Maryland, United States
      • Recruiting
    • Clinton, Maryland, United States
      • Recruiting
    • Hyattsville, Maryland, United States
      • Recruiting
    • Salisbury, Maryland, United States
      • Recruiting
    • Silver Spring, Maryland, United States
      • Terminated
    • Takoma Park, Maryland, United States
      • Recruiting
  • Massachusetts
    • Boston, Massachusetts, United States
      • Recruiting
  • Michigan
    • Lansing, Michigan, United States
      • Recruiting
    • Marquette, Michigan, United States
      • Terminated
    • Ypsilanti, Michigan, United States
      • Recruiting
  • Minnesota
    • Coon Rapids, Minnesota, United States
      • Recruiting
    • Minneapolis, Minnesota, United States
      • Recruiting
    • Robbinsdale, Minnesota, United States
      • Recruiting
    • Rochester, Minnesota, United States
      • Recruiting
    • Saint Cloud, Minnesota, United States
      • Recruiting
    • Saint Paul, Minnesota, United States
      • Terminated
  • Mississippi
    • Hattiesburg, Mississippi, United States
      • Terminated
  • Missouri
    • Columbia, Missouri, United States
      • Recruiting
    • Kansas City, Missouri, United States
      • Recruiting
    • Saint Louis, Missouri, United States
      • Recruiting
  • Nebraska
    • Omaha, Nebraska, United States
      • Recruiting
  • New Jersey
    • Marlton, New Jersey, United States
      • Recruiting
    • Morristown, New Jersey, United States
      • Recruiting
    • New Brunswick, New Jersey, United States
      • Terminated
    • Ocean City, New Jersey, United States
      • Recruiting
    • Ridgewood, New Jersey, United States
      • Recruiting
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Recruiting
  • New York
    • Huntington, New York, United States
      • Recruiting
    • Manhasset, New York, United States
      • Active, not recruiting
    • New York, New York, United States
      • Recruiting
    • Poughkeepsie, New York, United States
      • Recruiting
    • Utica, New York, United States
      • Recruiting
  • North Carolina
    • Durham, North Carolina, United States
      • Recruiting
    • Raleigh, North Carolina, United States
      • Recruiting
  • Ohio
    • Akron, Ohio, United States
      • Recruiting
    • Cincinnati, Ohio, United States
      • Recruiting
    • Cleveland, Ohio, United States
      • Recruiting
    • Columbus, Ohio, United States
      • Recruiting
    • Toledo, Ohio, United States
      • Suspended
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Recruiting
  • Oregon
    • Portland, Oregon, United States
      • Terminated
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • Recruiting
    • Bethlehem, Pennsylvania, United States
      • Recruiting
    • Danville, Pennsylvania, United States
      • Recruiting
    • Erie, Pennsylvania, United States
      • Recruiting
    • Lancaster, Pennsylvania, United States
      • Terminated
    • Philadelphia, Pennsylvania, United States
      • Active, not recruiting
    • Pittsburgh, Pennsylvania, United States
      • Recruiting
    • Wilkes-Barre, Pennsylvania, United States
      • Recruiting
  • South Carolina
    • Columbia, South Carolina, United States
      • Recruiting
  • Tennessee
    • Germantown, Tennessee, United States
      • Recruiting
    • Nashville, Tennessee, United States
      • Recruiting
  • Texas
    • Austin, Texas, United States
      • Recruiting
    • Dallas, Texas, United States
      • Recruiting
    • Fort Worth, Texas, United States
      • Recruiting
    • Houston, Texas, United States
      • Terminated
    • Plano, Texas, United States
      • Recruiting
    • The Woodlands, Texas, United States
      • Recruiting
    • Tyler, Texas, United States
      • Recruiting
  • Vermont
    • Burlington, Vermont, United States
      • Recruiting
  • Virginia
    • Charlottesville, Virginia, United States
      • Recruiting
  • Washington
    • Olympia, Washington, United States
      • Recruiting
    • Spokane, Washington, United States
      • Recruiting
  • Wisconsin
    • Madison, Wisconsin, United States
      • Recruiting
    • Milwaukee, Wisconsin, United States
      • Recruiting

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects implanted with Medtronic qualifying cardiac rhythm product.

Description

Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria:

• Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB

AND one of the following must also apply:

• Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
• Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data

Exclusion Criteria:

• Subjects who are, or will be inaccessible for follow-up
• Subjects with exclusion criteria required by local law (EMEA only)
• Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
• Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lead related complications for each lead model.	All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.	Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).

Collaborators and Investigators

• Sponsor: Medtronic
• Investigators: Study Chair: Product Performance Report Study Leader, Medtronic

Study record dates

Study Major Dates

• Study Start: January 1, 1983
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040

Study Registration Dates

• First Submitted: December 28, 2005
• First Submitted That Met QC Criteria: December 28, 2005
• First Posted (Estimated): December 30, 2005

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pacemaker; Implantable Cardioverter Defibrillator; Cardiac Pacing; Sinus Bradycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Supraventricular; Bradycardia; Tachycardia; Tachycardia, Sinus
• Other Study ID Numbers: 602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes