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Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

NCT03075215 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2044

Last updated 2023-10-25

Study results available
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Summary

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

Conditions

Interventions

DEVICE

Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)

The optimization during the standard of care visits in the first 12 months following implantation

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jose-Ignacio Garcia-Bolao, PhD, FESC · Clinica Universidad de Navarra

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-14
Primary Completion
2021-11-15
Completion
2021-11-15
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03075215 on ClinicalTrials.gov