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

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ClinicalTrials.gov Identifier: NCT01179997
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : February 27, 2014
Sponsor:
Collaborator:
Fundacio Clinic
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

Brief 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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

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



Primary Outcome Measures :
  1. 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 :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179997


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

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
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: May 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases