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
- Are there results?
- None posted in the registry
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
Study site
Anchorage, Alaska
Study site
Austin, Texas
Study site
Bakersfield, California
Study site
Baltimore, Maryland
Study site
Baton Rouge, Louisiana
Study site
Bethlehem, Pennsylvania
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Bradenton, Florida
Study site
Burlington, Vermont
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Clinton, Maryland
Study site
Columbia, Missouri
Study site
Columbia, South Carolina
Study site
Dallas, Texas
Study site
Danville, Pennsylvania
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Edgewood, Kentucky
Study site
Erie, Pennsylvania
Study site
Evansville, Indiana
Study site
Fort Worth, Texas
Study site
Garden City, New York
Study site
Germantown, Tennessee
Study site
Gilbert, Arizona
Study site
Huntington, New York
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Jonesboro, Arkansas
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Kingsport, Tennessee
Study site
Lakewood, Colorado
Study site
Lancaster, Pennsylvania
Study site
Lansing, Michigan
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Manhasset, New York
Study site
Marietta, Georgia
Study site
Marquette, Michigan
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Morristown, New Jersey
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Ocean Township, New Jersey
Study site
Palm Springs, California
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Plano, Texas
Study site
Portland, Oregon
Study site
Poughkeepsie, New York
Study site
Raleigh, North Carolina
Study site
Rancho Mirage, California
Study site
Redwood City, California
Study site
Robbinsdale, Minnesota
Study site
Rochester, Minnesota
Study site
Safety Harbor, Florida
Study site
Saint Louis Park, Minnesota
Study site
Salinas, California
Study site
Salisbury, Maryland
Study site
San Diego, California
Study site
Silver Spring, Maryland
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
Stanford, California
Study site
Takoma Park, Maryland
Study site
The Woodlands, Texas
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Utica, New York
Study site
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
Study site
Homburg
Study site
Tübingen
Study site
Ulm
France5 sites
Study site
Clermont-Ferrand
Study site
La Rochelle
Study site
Montpellier
Study site
Nantes
Study site
Pringy
Canada4 sites
Study site
Calgary
Study site
Kingston
Study site
Montreal
Study site
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized CRT - Product Surveillance Registry (PSR)
- ClinicalTrials.gov ID
- NCT03723265
- Acronym / sponsor ID
- Personalized CRT
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,517 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Jan 2012 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes patients that are or will be implanted with an eligible CRT system.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Resynchronization Therapy | Device | – |
Primary outcome
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.
3 secondary outcomes
Treatments for CRT non-response
Time frame: Every 3-9 months
Treatment effects for different CRT features in the CRT non-responder population
Time frame: Every 3-9 months
Patient outcome post initial CRT implant
Time frame: Every 3-9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
122 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic at 122 sites in 13 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: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in United States, Germany, France, Canada, Netherlands and 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRT Response (time frame: Every 3-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2022.