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

August 18, 2026 updated by: Medtronic

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Medtronic CRM Clinical Trials
Email: medtroniccrmtrials@medtronic.com

Study Locations

Australia
- - Chermside, Australia
    - Terminated
  - Douglas, Australia
    - Terminated
  - Murdoch, Australia
    - Terminated
  - Southport, Australia
    - Terminated
Austria
- - Graz, Austria
    - Recruiting
  - Innsbruck, Austria
    - Recruiting
  - Linz, Austria
    - Recruiting
  - Vienna, Austria
    - Recruiting
Belgium
- - Bruges, Belgium
    - Recruiting
  - Brussels, 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
    - Terminated
  - Dalian, China
    - Recruiting
  - Fuzhou, China
    - Terminated
  - Guangzhou, China
    - Recruiting
  - Hangzhou, China
    - Recruiting
  - Harbin, China
    - Recruiting
  - Kunming, China
    - Recruiting
  - Nanchang, China
    - Recruiting
  - Nanjing, China
    - Recruiting
  - Shanghai, China
    - Recruiting
  - Shantou, China
    - Terminated
  - Suining, China
    - Recruiting
  - Suzhou, China
    - Recruiting
  - Taiyuan, China
    - Terminated
  - Tianjin, China
    - Terminated
  - Ürümqi, China
    - Recruiting
Czechia
- - Prague, Czechia
    - Active, not recruiting
Denmark
- - Aarhus, Denmark
    - Terminated
  - Copenhagen, Denmark
    - Recruiting
  - Hellerup, Denmark
    - Active, not recruiting
  - Hillerød, Denmark
    - Terminated
  - Odense, Denmark
    - Recruiting
Finland
- - Helsinki, Finland
    - Recruiting
France
- - Avignon, France
    - Recruiting
  - Bayonne, France
    - Terminated
  - 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
    - Terminated
  - Paris, France
    - Recruiting
  - Pessac, France
    - Active, not recruiting
  - Pringy, France
    - Recruiting
  - Rennes, France
    - Active, not recruiting
  - Rouen, France
    - Recruiting
  - Saint-Priest-en-Jarez, France
    - Active, not recruiting
  - Strasbourg, France
    - Terminated
  - Toulouse, France
    - Recruiting
  - Vandœuvre-lès-Nancy, France
    - Active, not recruiting
  - Villeurbanne, France
    - Active, not recruiting
Germany
- - Aachen, Germany
    - Recruiting
  - Bad Oeynhausen, Germany
    - Recruiting
  - Bielefeld, Germany
    - Recruiting
  - Bremen, Germany
    - Recruiting
  - Cologne, Germany
    - Recruiting
  - Dresden, Germany
    - Terminated
  - Düsseldorf, Germany
    - Recruiting
  - Essen, Germany
    - Terminated
  - Hamburg, Germany
    - Terminated
  - Hanover, Germany
    - Recruiting
  - Heidelberg, Germany
    - Terminated
  - Homburg, Germany
    - Terminated
  - Jena, Germany
    - Completed
  - München, Germany
    - Recruiting
  - Münster, Germany
    - Completed
  - Tübingen, Germany
    - Terminated
  - Ulm, Germany
    - Recruiting
  - Villingen-Schwenningen, Germany
    - Terminated
Greece
- - Athens, Greece
    - Recruiting
  - Marousi, Greece
    - Active, not recruiting
  - Thessaloniki, Greece
    - Recruiting
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
Hungary
- - Budapest, Hungary
    - Recruiting
Iceland
- - Reykjavik, Iceland
    - Terminated
India
- - Bangalore, India
    - Recruiting
  - Chennai, India
    - Recruiting
  - Gurgaon, India
    - Recruiting
  - Hyderabad, India
    - Recruiting
  - Jaipur, India
    - Recruiting
  - Kochi, India
    - Recruiting
  - New Delhi, India
    - Recruiting
Israel
- - Ashkelon, Israel
    - Recruiting
  - Beersheba, Israel
    - Terminated
  - Jerusalem, Israel
    - Recruiting
  - Ramat Gan, Israel
    - Recruiting
Italy
- - Ancona, Italy
    - Terminated
  - Bari, Italy
    - Recruiting
  - Bologna, Italy
    - Recruiting
  - Brescia, Italy
    - Active, not recruiting
  - Castrovillari, Italy
    - Recruiting
  - Cotignola, Italy
    - Completed
  - Lecce, Italy
    - Recruiting
  - Milan, Italy
    - Recruiting
  - Monza, Italy
    - Recruiting
  - Pisa, Italy
    - Completed
  - Taranto, Italy
    - Recruiting
  - Udine, Italy
    - Recruiting
Japan
- - Ageo, Japan
    - Recruiting
  - Bunkyō City, Japan
    - Recruiting
  - Gifu, Japan
    - Recruiting
  - Hidaka, Japan
    - Recruiting
  - Hiroshima, Japan
    - Recruiting
  - Kagoshima, Japan
    - Recruiting
  - Kamakura, Japan
    - Recruiting
  - Kawasaki, Japan
    - Recruiting
  - Kitakyushu, Japan
    - Recruiting
  - Koshigaya, Japan
    - Recruiting
  - Kumamoto, Japan
    - Recruiting
  - Kyoto, Japan
    - Recruiting
  - Minatoku, Japan
    - Completed
  - Mitaka, Japan
    - Recruiting
  - Nagoya, Japan
    - Recruiting
  - Niigata, Japan
    - Recruiting
  - Okayama, Japan
    - Recruiting
  - Sapporo, Japan
    - Recruiting
  - Shinagawa-Ku, Japan
    - Recruiting
  - Shizuoka, Japan
    - Recruiting
  - Suita, Japan
    - Recruiting
  - Tokyo, Japan
    - Terminated
  - Toyoake, Japan
    - Recruiting
  - Tsukuba, Japan
    - Recruiting
  - Urasoe, Japan
    - Recruiting
  - Yamagata, Japan
    - Terminated
  - Yokohama, Japan
    - Recruiting
  - Ōsaka-sayama, Japan
    - Terminated
Kuwait
- - Hadiya, Kuwait
    - Terminated
  - Kuwait City, Kuwait
    - Recruiting
Malaysia
- - Kuala Lumpur, Malaysia
    - Recruiting
Netherlands
- - Amsterdam, Netherlands
    - Active, not recruiting
  - Breda, Netherlands
    - Terminated
  - 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
  - The Hague, Netherlands
    - Active, not recruiting
New Zealand
- - Christchurch, New Zealand
    - Active, not recruiting
Norway
- - Bergen, Norway
    - Recruiting
  - Oslo, Norway
    - Terminated
  - Trondheim, Norway
    - Recruiting
Poland
- - Poznan, Poland
    - Active, not recruiting
  - Warsaw, Poland
    - Recruiting
  - Zabrze, Poland
    - Active, not recruiting
Portugal
- - Carnaxide, Portugal
    - Recruiting
  - Creixomil, Portugal
    - Recruiting
  - Lisbon, Portugal
    - Active, not recruiting
  - Porto, Portugal
    - Recruiting
  - Santarém, Portugal
    - Recruiting
Saudi Arabia
- - Jeddah, Saudi Arabia
    - Recruiting
  - Riyadh, Saudi Arabia
    - Completed
Serbia
- - Belgrade, Serbia
    - Recruiting
Slovakia
- - Bratislava, Slovakia
    - Recruiting
  - Košice, Slovakia
    - Terminated
Slovenia
- - Ljubljana, Slovenia
    - Terminated
South Korea
- - Busan, South Korea
    - Completed
  - Cheongju-si, South Korea
    - Completed
  - Daegu, South Korea
    - Completed
  - Daejeon, South Korea
    - Completed
  - Gwangju, South Korea
    - Completed
  - Gyeonggi-do, South Korea
    - Recruiting
  - Jeonju, South Korea
    - Completed
  - Seongnam-si, South Korea
    - Completed
  - Seoul, South Korea
    - Recruiting
  - Suwon, South Korea
    - Completed
  - Yangsan, South Korea
    - Completed
Spain
- - A Coruña, Spain
    - Recruiting
  - Barcelona, Spain
    - Active, not recruiting
  - Córdoba, Spain
    - Recruiting
  - Girona, 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
  - Valencia, Spain
    - Recruiting
  - Valladolid, Spain
    - Recruiting
  - Vitoria-Gasteiz, Spain
    - Active, not recruiting
Sweden
- - Gothenburg, Sweden
    - Recruiting
  - Lund, Sweden
    - Recruiting
  - Skövde, Sweden
    - Recruiting
  - Uppsala, Sweden
    - Terminated
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
  - Zurich, Switzerland
    - Recruiting
United Kingdom
- - Birmingham, United Kingdom
    - Recruiting
  - Blackpool, United Kingdom
    - Terminated
  - 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
    - Terminated
  - 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
    - Terminated
- Arizona
  - Chandler, Arizona, United States
    - Recruiting
- Arkansas
  - Jonesboro, Arkansas, United States
    - Terminated
  - Little Rock, Arkansas, United States
    - Recruiting
- California
  - Bakersfield, California, United States
    - Terminated
  - Chula Vista, California, United States
    - Completed
  - La Jolla, California, United States
    - Recruiting
  - Los Angeles, California, United States
    - Terminated
  - Palm Springs, California, United States
    - Terminated
  - Rancho Mirage, California, United States
    - Terminated
  - Redwood City, California, United States
    - Active, not recruiting
  - Salinas, California, United States
    - Recruiting
  - San Diego, California, United States
    - Terminated
  - Stanford, California, United States
    - Recruiting
  - Torrance, California, United States
    - Recruiting
  - Van Nuys, California, United States
    - Terminated
  - Ventura, California, United States
    - Recruiting
- Colorado
  - Aurora, Colorado, United States
    - Recruiting
  - 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 D.C., 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
  - Tampa, 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
    - Terminated
  - Shreveport, Louisiana, United States
    - Terminated
- Maryland
  - Baltimore, Maryland, United States
    - Terminated
  - Bethesda, Maryland, United States
    - Recruiting
  - Clinton, Maryland, United States
    - Terminated
  - 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
  - St Louis, Missouri, United States
    - Recruiting
- Nebraska
  - Omaha, Nebraska, United States
    - Recruiting
- New Jersey
  - Eatontown, New Jersey, United States
    - Recruiting
  - 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
  - Port Jefferson, New York, United States
    - Recruiting
  - Poughkeepsie, New York, United States
    - Recruiting
  - Utica, New York, United States
    - Terminated
- North Carolina
  - Durham, North Carolina, United States
    - Recruiting
  - Raleigh, North Carolina, United States
    - Recruiting
- Ohio
  - Akron, Ohio, United States
    - Terminated
  - Cincinnati, Ohio, United States
    - Recruiting
  - Cleveland, Ohio, United States
    - Recruiting
  - Columbus, Ohio, United States
    - Recruiting
  - Toledo, Ohio, United States
    - Recruiting
- 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
    - 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
    - Recruiting
  - Plano, Texas, United States
    - Recruiting
  - The Woodlands, Texas, United States
    - Terminated
  - Tyler, Texas, United States
    - Recruiting
- Vermont
  - Burlington, Vermont, United States
    - Recruiting
- Virginia
  - Charlottesville, Virginia, United States
    - Recruiting
  - Falls Church, Virginia, United States
    - Recruiting
- Washington
  - Olympia, Washington, United States
    - Recruiting
  - Spokane, Washington, United States
    - Active, not recruiting
- Wisconsin
  - Madison, Wisconsin, United States
    - Recruiting
  - Milwaukee, Wisconsin, United States
    - Recruiting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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. Time Frame: 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).	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

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

Study Chair: Product Performance Report Study Leader, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.