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Left Ventricular Capture Management Study

NCT01089634 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 151

Last updated 2018-04-26

No results posted yet for this study

Summary

Primary Objective:

To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements.

Study Design:

This is a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design, based on the primary objective, is an observational examination of LV thresholds over time. Daily left ventricular threshold measurements will be collected using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary objective at up to 15 study centers.

Data will be collected at Baseline, Implant, 12 months post-implant and all regularly scheduled follow-up visits up to 12 months post-implant.

Devices:

The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM feature will be used in this study.

Conditions

  • Ventricular Fibrillation
  • Ventricular Tachycardia
  • Bradyarrhythmia

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Mary McCann, R.N., MBA · Medtronic

  • Allison Rubino · Medtronic

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Canada

Study Locations

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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 NCT01089634 on ClinicalTrials.gov