Cardiac Strains for Optimization of CRT in Non-Responders
- Conditions
- Chronic Heart Failure
- Interventions
- Device: CRT-D re-programmingDiagnostic Test: Trans-Thoracic Echocardiography
- Registration Number
- NCT03803826
- Lead Sponsor
- University Hospital Ostrava
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- patients with symptomatic heart failure with NYHA III/IV, pharmacological treatment options exhausted, LVEF below 30%, and QRS duration over 130ms who did not respond to the implantation of CRT-D
- Age below 18
- response to the original CRT implantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRT-D re-programming 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 Trans-Thoracic Echocardiography 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
- Primary Outcome Measures
Name Time Method Change in the left ventricular ejection fraction 6 months from CRT-D implantation, 3 months from optimization Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing
- Secondary Outcome Measures
Name Time Method Change in NYHA Classification 6 months from CRT-D implantation, 3 months from optimization 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
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Czechia