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

This study has been completed.
Sponsor:
Collaborator:
Fundacio Clinic
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01179997
First received: August 5, 2010
Last updated: February 26, 2014
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Heart Failure
Cardiac Resynchronization Therapy
Device: Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves
Device: Electrocardiographic optimization of the interventricular pacing delay according to QRS width
Phase 3

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

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 6-month echocardiographic response [ Designated as safety issue: No ]
    Reduction of the end-systolic volume (measured in mililiters according to transthoracic echocardiography) of >10% as compared to the baseline value.


Secondary Outcome Measures:
  • 6-month clinical response [ Designated as safety issue: No ]
    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.


Enrollment: 156
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179997

Locations
Spain
Hospital Clinic Universitari
Barcelona, Catalonia, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fundacio Clinic
  More Information

No publications provided

Responsible Party: Josep Lluis Mont Girbau, MD PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01179997     History of Changes
Other Study ID Numbers: CRT-opt
Study First Received: August 5, 2010
Last Updated: February 26, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014