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Personalized CRT - MPP Post Approval Study

NCT03232944 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1338

Last updated 2021-02-17

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Cardiac Resynchronization Therapy - MPP

The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2020-06-04
Completion
2021-01-07

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Malaysia
  • Netherlands
  • Slovakia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03232944 on ClinicalTrials.gov