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The aim of this study is to investigate the possibility of optimizing the performance of CRT-D in non-responding patients through utilization of cardiac strain speckle tracking
In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to any improvement of the patients' status.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT-D re-programming | Experimental | The ineffective previously implanted CRT-D is reprogrammed under supervision of transthoracic echocardiography to:
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 |
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| Control Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D re-programming | Device | The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the left ventricular ejection fraction | Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing | 6 months from CRT-D implantation, 3 months from optimization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NYHA Classification | NYHA (New York Heart Association Classification measured using the standard NYHA range I to IV - I being the best result, IV the worst) was evaluated using a standard NYHA questionnaire before optimization and 3 months after optimization during a follow-up examination | 6 months from CRT-D implantation, 3 months from optimization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sipula, MUDr. | University Hospital Ostrava, Dpt of Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | 70800 | Czechia |
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Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months from implementation are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap, the interventricular interval iss 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 the use of other strain combinations assessed.
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| Trans-Thoracic Echocardiography | Diagnostic Test | 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. |
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