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Guided Placement of CRT-Leads

NCT00764075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2011-07-07

No results posted yet for this study

Summary

In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

Conditions

Interventions

DEVICE

Beutel TM

application of BeutelTM

OTHER

standard

standard procedure will be applied but no Beutel TM software

DEVICE

software Beutel TM

application of BeutelTM to patients data for determination of site of latest contraction

Sponsors & Collaborators

  • University of Chicago

    collaborator OTHER

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Christian Knackstedt, MD · RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • Germany

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 NCT00764075 on ClinicalTrials.gov