Personalized CRT - PSR

May 19, 2022 updated by: Medtronic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1517

Contacts and Locations

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

Study Locations

  • Belgium
      • Leuven, Belgium
      • Yvoir, Belgium
  • Canada
      • Calgary, Canada
      • Kingston, Canada
      • Montreal, Canada
      • Québec, Canada
  • France
      • Clermont-Ferrand, France
      • La Rochelle, France
      • Montpellier, France
      • Nantes, France
      • Pringy, France
  • Germany
      • Aachen, Germany
      • Essen, Germany
      • Hannover, Germany
      • Homburg, Germany
      • Köln, Germany
      • Tübingen, Germany
      • Ulm, Germany
  • Italy
      • Milano, Italy
      • Reggio Emilia, Italy
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Kuala Lumpur, Malaysia
  • Netherlands
      • Eindhoven, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
  • Serbia
      • Belgrade, Serbia
  • Spain
      • A Coruña, Spain
      • Palma de Mallorca, Spain
  • Sweden
      • Skövde, Sweden
  • United Kingdom
      • Birmingham, United Kingdom
      • Liverpool, United Kingdom
      • Manchester, United Kingdom
      • Middlesbrough, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Gilbert, Arizona, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Chula Vista, California, United States
      • Palm Springs, California, United States
      • Rancho Mirage, California, United States
      • Redwood City, California, United States
      • Salinas, California, United States
      • San Diego, California, United States
      • Stanford, California, United States
      • Torrance, California, United States
      • Van Nuys, California, United States
    • Colorado
      • Denver, Colorado, United States
      • Lakewood, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bradenton, Florida, United States
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Safety Harbor, Florida, United States
    • Georgia
      • Albany, Georgia, United States
      • Marietta, Georgia, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
    • Iowa
      • West Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Edgewood, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Clinton, Maryland, United States
      • Salisbury, Maryland, United States
      • Silver Spring, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
      • Marquette, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Robbinsdale, Minnesota, United States
      • Rochester, Minnesota, United States
      • Saint Louis Park, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Morristown, New Jersey, United States
      • Ocean Township, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Garden City, New York, United States
      • Huntington, New York, United States
      • Manhasset, New York, United States
      • New York, New York, United States
      • Poughkeepsie, New York, United States
      • Utica, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Wilkes-Barre, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Plano, Texas, United States
      • The Woodlands, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population includes patients that are or will be implanted with an eligible CRT system.

Description

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 CRT device
  • Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRT Response
Time Frame: Every 3-9 months
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.
Every 3-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatments for CRT non-response
Time Frame: Every 3-9 months
Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives.
Every 3-9 months
Treatment effects for different CRT features in the CRT non-responder population
Time Frame: Every 3-9 months
A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response.
Every 3-9 months
Patient outcome post initial CRT implant
Time Frame: Every 3-9 months
Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death.
Every 3-9 months

Collaborators and Investigators

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

Sponsor

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, 2012

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

April 28, 2022

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 26, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Personalized CRT

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.

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