Cardiac Strains for Optimization of CRT in Non-Responders
NCT ID: NCT03803826
Last Updated: 2022-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-01-01
2019-12-01
Brief Summary
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Detailed Description
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In this study, an investigation of a possible method of optimization through speckle tracking of cardiac strains is attempted.
Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap and the interventricular interval subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and use of other strain combinations assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CRT-D re-programming
The ineffective previously implanted CRT-D is reprogrammed under supervision of transthoracic echocardiography to:
1. adjust the atrioventricular interval so that E and A waves do not overlap
2. the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
Transthoracic echocardiography is performed prior to optimization and 3 months after optimization (i.e., 3 and 6 months after the CRT implantation) and and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods re-programming of the interventricular interval
CRT-D re-programming
The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to:
1. adjust the atrioventricular interval so that E and A waves do not overlap
2. the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
Trans-Thoracic Echocardiography
This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D
Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.
Control Group
Only trans-thoracic echocardiography is performed during follow-ups at 3 and 6 months from CRT implantations performed and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods
No interventions assigned to this group
Interventions
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CRT-D re-programming
The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to:
1. adjust the atrioventricular interval so that E and A waves do not overlap
2. the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
Trans-Thoracic Echocardiography
This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D
Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* response to the original CRT implantation
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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David Sipula, MUDr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava, Dpt of Cardiovascular Diseases
Locations
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University Hospital Ostrava
Ostrava, , Czechia
Countries
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Other Identifiers
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FNO-STRAINS
Identifier Type: -
Identifier Source: org_study_id
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