Personalized CRT - MPP Post Approval Study

Completed

• Conditions: Heart Failure

• Registration Number: NCT03232944
• Lead Sponsor: Medtronic

Brief 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. 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 Timeline

• Study Start: 2017-07-05
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-28
• Primary Completion: 2020-06-04
• Study Completion: 2021-01-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1338

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MPP therapy responder	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".

Secondary Outcome Measures

Name	Time	Method
HF hospitalization and/or mortality	Up to 3 years	Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled

Trial Locations

Locations (78)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Saint Vincent Heart Clinic Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Chula Vista Cardiac Center; 🇺🇸 Chula Vista, California, United States

Desert Heart Rhythm Consultants; 🇺🇸 Palm Springs, California, United States

COR Healthcare; 🇺🇸 Torrance, California, United States

Colorado Springs Cardiology; 🇺🇸 Colorado Springs, Colorado, United States

Denver Heart; 🇺🇸 Denver, Colorado, United States

Colorado Heart and Vascular, PC; 🇺🇸 Lakewood, Colorado, United States

Heart Rhythm Solutions; 🇺🇸 Hollywood, Florida, United States

Baptist Health; 🇺🇸 Jacksonville, Florida, United States

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