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Tailor-CRT: Better Application of Cardiac Resynchronization Therapy

NCT02326493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-23

No results posted yet for this study

Summary

Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement and programming of atrio-ventricular (AV) and inter-ventricular (VV) stimulation intervals to the individual patient. However, the best strategy to optimize lead positioning and device programming still remains to be established. Earlier work in our research group suggests that the vector cardiogram (VCG) can be used to determine the optimal LV lead position and AV- and VV-intervals, and pilot studies showed the feasibility to derive a VCG-like signal (D-VCG) from the implanted pacing electrodes. Other studies have suggested that the best position for the LV electrode is the region of latest electrical activation. The region of latest electrical activation can be identified by measuring the electrical delay on the LV lead (LVLED) during implantation. The objective of this study is to investigate whether D-VCG can be used to determine the optimal AV- and VV-interval and whether VCG and LVLED can be used to determine the optimal LV lead position.

Conditions

Interventions

DEVICE

Cardiac Resynchronization Therapy

A CRT device will be implanted while performing extra hemodynamic (LV dP/dtmax) and electrical (LVLED, VCG, and D-VCG) measurements. Devices and leads from various vendors will be used.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Kevin Vernooy, MD, PhD · Maastricht University Medical Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Netherlands

Study Locations

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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 NCT02326493 on ClinicalTrials.gov