Personalized CRT - MPP Post Approval Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/19/2018 |
| Start Date: | July 5, 2017 |
| End Date: | July 5, 2020 |
| Contact: | MPP PAS Study Team |
| Email: | rs.productsurveillanceregistry@medtronic.com |
| Phone: | 1-800-633-8766 |
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).
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).
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
We found this trial at
42
sites
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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