Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)

February 26, 2014 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
The aim of this study was to compare the response to cardiac resynchronization therapy when the interventricular pacing interval was optimized by Tissue Doppler Imaging (TDI) to response when it was optimized following QRS width criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital Clinic Universitari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tissue Doppler Imaging (TDI) optimization
Interventricular pacing delay optimized according to Tissue-Doppler echocardiography
Device: Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves
Active Comparator: Electrocardiographic optimization
Interventricular pacing delay optimized according to QRS width observation in the 12-lead surface electrocardiogram
Device: Electrocardiographic optimization of the interventricular pacing delay according to QRS width

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
6-month echocardiographic response
Reduction of the end-systolic volume (measured in mililiters according to transthoracic echocardiography) of >10% as compared to the baseline value.

Secondary Outcome Measures

Outcome Measure
Measure Description
6-month clinical response
Combined end-point consisting in no death due to cardiovascular reasons, no heart transplantation and distance increase of >10% (measured in meters) in the 6-minute walking test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundacio Clinic Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT-opt

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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