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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179997
• Other study ID #: CRT-opt
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2010
• Last updated: February 26, 2014

Study information

• Verified date: May 2010
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Device:
• Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves

• Electrocardiographic optimization of the interventricular pacing delay according to QRS width

Locations

Country	Name	City	State
Spain	Hospital Clinic Universitari	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundacio Clinic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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.		No