Heart FailureNCT03232944
Personalized CRT - MPP Post Approval Study
An observational study of Heart Failure, run by Medtronic at 78 sites in 13 countries.
Trial summary
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. 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 - MPP
- Type of treatment
- Medical device
- How many people
- 1,338 participants
- Where
- 78 sitesin 13 countries
- Study dates
- 5 Jul 2017to 7 Jan 2021
- How long will I take part?
- 3 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes patients that are or will be implanted with an eligible CRT Quad 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
78 sites in 13 countries.
78 sites in 13 countries
United States46 sites
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, 44304-1473
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Presbyterian Heart Group
Albuquerque, New Mexico, 87106-4921
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103-6381
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
MedStar Health Research Institute
Baltimore, Maryland, 21237-3958
The Johns Hopkins Hospital
Bethesda, Maryland, 20817
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0001
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The University of Vermont Medical Center
Burlington, Vermont, 05401
Chula Vista Cardiac Center
Chula Vista, California, 91910
The Christ Hospital Health Network
Cincinnati, Ohio, 45219
University of Cincinnati
Cincinnati, Ohio, 45267-0542
Cleveland Clinic
Cleveland, Oklahoma, 44195-0001
Colorado Springs Cardiology
Colorado Springs, Colorado, 80907
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201-8023
Geisinger Medical Center
Danville, Pennsylvania, 17822
Denver Heart
Denver, Colorado, 80204
Island Cardiac Specialists
Garden City, New York, 11530-1613
HealthCare Partners Medical Group
Henderson, Nevada, 89052-4171
Heart Rhythm Solutions
Hollywood, Florida, 33021
Huntington Hospital
Huntington, New York, 11743-2787
Baptist Health
Jacksonville, Florida, 32207
The University of Kansas Medical Center
Kansas City, Kansas, 66160-8500
Colorado Heart and Vascular, PC
Lakewood, Colorado, 80228
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205-6202
Northwell Health
Manhasset, New York, 11030
UP Health System - Marquette
Marquette, Michigan, 49855-2705
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407-1157
Saint Thomas Research Institute
Nashville, Tennessee, 37205-2018
Desert Heart Rhythm Consultants
Palm Springs, California, 92262
Hudson Valley Heart Center
Poughkeepsie, New York, 12601-3923
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
North Memorial Heart and Vascular Institute
Robbinsdale, Minnesota, 55422
Mayo Clinic
Rochester, Minnesota, 55905
Heart & Vascular Institute of Florida
Safety Harbor, Florida, 34695-6604
Delmarva Heart Research Foundation Inc
Salisbury, Maryland, 21804-6938
Kootenai Heart Clinics Northwest
Spokane, Washington, 99204-2352
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Mercy Health - Saint Vincent Medical Center
Toledo, Ohio, 43608
COR Healthcare
Torrance, California, 90505
Central New York Cardiology
Utica, New York, 13501-5930
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Michigan Heart
Ypsilanti, Michigan, 48197-8633
France6 sites
CHRU Brest - Hôpital de la Cavale Blanche
Brest, 29609
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, 63003
CHRU La Rochelle
La Rochelle, 17019
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Nouvelles Cliniques Nantaises
Nantes, 44277
Centre hospitalier de la région d'Annecy
Pringy, 74374
Germany6 sites
Universitätsklinikum Aachen, AöR
Aachen, 52074
St. Vinzenz-Hospital Köln
Cologne, 50733
Universitätsklinikum Essen
Essen, 045147
Universitätsklinikum des Saarlandes
Homburg, 66421
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89081
United Kingdom5 sites
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, B15 2GW
Glenfield Hospital
Leicester, LE3 9QP
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester, M13 9WL
The James Cook University Hospital - South Tees Hospitals NHS
Middlesbrough, TS4 3BW
Spain4 sites
Hospital Universitario da Coruña
A Coruña, 15006
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario Son Espases
Palma de Mallorca, 07210
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15706
Belgium2 sites
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
CHU UCL Mont-Godinne - Dinant
Yvoir, 5530
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
Netherlands2 sites
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
Maasstad Hospital Rotterdam
Rotterdam, 3079 DZ
Malaysia1 site
Institut Jantung Negara - National Heart Institute
Kuala Lumpur, 50400
Slovakia1 site
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Košice, 04011
About this study
Official title: Personalized CRT - Multiple Point Pacing Post Approval Study
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).
Read the detailed description
Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.
The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy - MPP
- 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 Therapy - MPPDevice
The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.
| Study group | Role | What they receive |
|---|---|---|
| CRT non-responders with MPP enabled | Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled. Receives: Device: Cardiac Resynchronization Therapy - MPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPP therapy responder
To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
Measured: Up to 3 years
Secondary outcomes (1)
HF hospitalization and/or mortality
Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start5 Jul 2017
- Primary completion4 Jun 2020
- Study completion7 Jan 2021
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
- 1,338 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232944
- Sponsor's protocol ID
- MPP PAS
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2017
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized CRT - Multiple Point Pacing Post Approval Study
- ClinicalTrials.gov ID
- NCT03232944
- Acronym / sponsor ID
- MPP PAS
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,338 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 28 Jul 2017 (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 Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).
Detailed description
Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.
The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT non-responders with MPP enabled | – | Device: Cardiac Resynchronization Therapy - MPPPatients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes patients that are or will be implanted with an eligible CRT Quad 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 - MPPThe multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes. | Device | CRT non-responders with MPP enabled |
Primary outcome
MPP therapy responder
Time frame: Up to 3 years
To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
1 secondary outcome
HF hospitalization and/or mortality
Time frame: Up to 3 years
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 17 Feb 2021.
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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.
78 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 78 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, France, Germany, United Kingdom, Spain 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?
MPP therapy responder (time frame: Up to 3 years). 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 17 Feb 2021.