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Completed

NCT Number: NCT03257436

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mobile Infirmary Medical Center, Mobile, Alabama, United States

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About this study

Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
  • Subjects must meet BSC labeled indication for CRT-D implantation.
  • Subjects must have a functional RA lead and RV lead implanted
  • Subjects who are willing and capable of providing informed consent
  • Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
  • Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

  • Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
  • Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
  • Subjects with documented history of permanent AF
  • Subjects with documented permanent complete AV block
  • Subjects who are expected to receive a heart transplant during the 12 months course of the study
  • Subjects with documented life expectancy of less than 12 months
  • Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC

Treatment and study plan

CRT-D

Device

Left Ventricular MultiSite Pacing

Primary outcomes

  1. LV MSP Feature Related Complication-Free Rate

    Time frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.

    Proportion of subjects free from LVMSP feature related complications at 12 months

  2. Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months

    Time frame: 12 Month Follow Up

    Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: SMARTMSP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2017
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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