Tissue Doppler Imaging (TDI) Versus Electrocardiography (ECG) Interventricular Pacing Delay Optimization in Cardiac Resynchronization Therapy (CRT)
1 other identifier
interventional
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedFebruary 27, 2014
May 1, 2010
August 5, 2010
February 26, 2014
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (1)
6-month clinical response
Study Arms (2)
Tissue Doppler Imaging (TDI) optimization
ACTIVE COMPARATORInterventricular pacing delay optimized according to Tissue-Doppler echocardiography
Electrocardiographic optimization
ACTIVE COMPARATORInterventricular pacing delay optimized according to QRS width observation in the 12-lead surface electrocardiogram
Interventions
Eligibility Criteria
You may qualify if:
- Patients submitted to de novo implant due to conventional cardiac resynchronization therapy indications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Fundacio Clinic Barcelonacollaborator
Study Sites (1)
Hospital Clinic Universitari
Barcelona, Catalonia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 11, 2010
Last Updated
February 27, 2014
Record last verified: 2010-05