Back to resultsTissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)
Primary Purpose
Heart Failure, Cardiac Resynchronization Therapy
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves
Electrocardiographic optimization of the interventricular pacing delay according to QRS width
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.
Exclusion Criteria:
-
Sites / Locations
- Hospital Clinic Universitari
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tissue Doppler Imaging (TDI) optimization
Electrocardiographic optimization
Arm Description
Interventricular pacing delay optimized according to Tissue-Doppler echocardiography
Interventricular pacing delay optimized according to QRS width observation in the 12-lead surface electrocardiogram
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT01179997
First Posted
August 5, 2010
Last Updated
February 26, 2014
Sponsor
Hospital Clinic of Barcelona
Collaborators
Fundacio Clinic Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01179997
Brief Title
Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Fundacio Clinic Barcelona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Resynchronization Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tissue Doppler Imaging (TDI) optimization
Arm Type
Active Comparator
Arm Description
Interventricular pacing delay optimized according to Tissue-Doppler echocardiography
Arm Title
Electrocardiographic optimization
Arm Type
Active Comparator
Arm Description
Interventricular pacing delay optimized according to QRS width observation in the 12-lead surface electrocardiogram
Intervention Type
Device
Intervention Name(s)
Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves
Intervention Type
Device
Intervention Name(s)
Electrocardiographic optimization of the interventricular pacing delay according to QRS width
Primary Outcome Measure Information:
Title
6-month echocardiographic response
Description
Reduction of the end-systolic volume (measured in mililiters according to transthoracic echocardiography) of >10% as compared to the baseline value.
Secondary Outcome Measure Information:
Title
6-month clinical response
Description
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.
Exclusion Criteria:
-
Facility Information:
Facility Name
Hospital Clinic Universitari
City
Barcelona
State/Province
Catalonia
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)
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