Heart FailureNCT03723265
Personalized CRT - PSR
An observational study of Heart Failure, run by Medtronic at 122 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- How many people
- 1,517 participants
- Where
- 122 sitesin 13 countries
- Study dates
- Jan 2012to 28 Apr 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
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
- Child, Adult, Older adult
Study population: The study population includes patients that are or will be implanted with an eligible CRT system.
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 CRT device
- Patient within 30 days of therapy received at the time of their initial PSR platform enrollment
Who cannot join
- Patient who is, or is expected to 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
122 sites in 13 countries.
122 sites in 13 countries
United States88 sites
Study site
Akron, Ohio
Study site
Albany, Georgia
Study site
Albuquerque, New Mexico
Study site
Allentown, Pennsylvania
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Anchorage, Alaska
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Austin, Texas
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Bakersfield, California
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Baltimore, Maryland
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Baton Rouge, Louisiana
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Bethlehem, Pennsylvania
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Birmingham, Alabama
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Boston, Massachusetts
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Bradenton, Florida
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Burlington, Vermont
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Chula Vista, California
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Clinton, Maryland
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Columbia, Missouri
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Columbia, South Carolina
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Dallas, Texas
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Danville, Pennsylvania
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Denver, Colorado
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Durham, North Carolina
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Edgewood, Kentucky
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Erie, Pennsylvania
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Evansville, Indiana
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Fort Worth, Texas
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Garden City, New York
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Germantown, Tennessee
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Gilbert, Arizona
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Huntington, New York
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Indianapolis, Indiana
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Jacksonville, Florida
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Jonesboro, Arkansas
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Kansas City, Kansas
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Kansas City, Missouri
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Kingsport, Tennessee
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Lakewood, Colorado
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Lancaster, Pennsylvania
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Lansing, Michigan
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Las Vegas, Nevada
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Little Rock, Arkansas
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Louisville, Kentucky
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Madison, Wisconsin
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Manhasset, New York
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Marietta, Georgia
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Marquette, Michigan
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Morristown, New Jersey
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Nashville, Tennessee
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New Haven, Connecticut
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New Orleans, Louisiana
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New York, New York
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Ocean Township, New Jersey
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Palm Springs, California
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Plano, Texas
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Portland, Oregon
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Poughkeepsie, New York
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Raleigh, North Carolina
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Rancho Mirage, California
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Redwood City, California
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Robbinsdale, Minnesota
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Rochester, Minnesota
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Safety Harbor, Florida
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Saint Louis Park, Minnesota
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Salinas, California
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Salisbury, Maryland
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San Diego, California
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Silver Spring, Maryland
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Spokane, Washington
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St Louis, Missouri
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Stanford, California
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Takoma Park, Maryland
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The Woodlands, Texas
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Toledo, Ohio
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Torrance, California
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Utica, New York
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Van Nuys, California
Study site
Washington D.C., District of Columbia
Study site
West Des Moines, Iowa
Study site
Wilkes-Barre, Pennsylvania
Study site
Worcester, Massachusetts
Study site
Ypsilanti, Michigan
Germany7 sites
Study site
Aachen
Study site
Cologne
Study site
Essen
Study site
Hanover
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Homburg
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Tübingen
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Ulm
France5 sites
Study site
Clermont-Ferrand
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La Rochelle
Study site
Montpellier
Study site
Nantes
Study site
Pringy
Canada4 sites
Study site
Calgary
Study site
Kingston
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Montreal
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Québec
Netherlands4 sites
Study site
Eindhoven
Study site
Maastricht
Study site
Nieuwegein
Study site
Rotterdam
United Kingdom4 sites
Study site
Birmingham
Study site
Liverpool
Study site
Manchester
Study site
Middlesbrough
About this study
Official title: Personalized CRT - Product Surveillance Registry (PSR)
The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.
Read the detailed description
The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
CRT Response
A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits.
Measured: Every 3-9 months
Secondary outcomes (3)
Treatments for CRT non-response
Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives.
Measured: Every 3-9 months
Treatment effects for different CRT features in the CRT non-responder population
A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response.
Measured: Every 3-9 months
Patient outcome post initial CRT implant
Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death.
Measured: Every 3-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study startJan 2012
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,517 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723265
- Sponsor's protocol ID
- Personalized CRT
- Status last verified
- May 2022
- First submitted
- 15 Oct 2018
- Last updated
- 20 May 2022
- Results posted
- No