Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis. Cardiac resynchronization therapy (CRT) has been one of the most important advancements in the past two decades for patients with LBBB heart failure. However, 30-40% of patients receiving a CRT do not benefit from it. In this study, the investigators will test a noninvasive device to evaluate acute effect of CRT during implantation and at follow-up CRT controls. In addition, echocardiography will be performed during CRT turned ON and OFF to visualize the changes in intraventricular flow and functional parameters of the heart.
Study Type
OBSERVATIONAL
Enrollment
80
Cardiac resynchronization therapy (CRT) is a modality of cardiac pacing used in patients with left ventricular (LV) systolic dysfunction and dyssynchronous ventricular activation that provides simultaneous or nearly simultaneous electrical activation of the LV and right ventricle (RV) via stimulation of the LV and RV (biventricular pacing) or LV alone.
Oslo University Hospital
Oslo, Norway
RECRUITINGReverse remodelling at 6 months follow-up
Measured by left ventricular end-systolic volume reduction of at least 15% assessed by echocardiography
Time frame: 6 months
Hospitalization
* all cause hospitalization * heart failure hospitalization defined by symptom, signs and biochemistry (NT-proBNP)
Time frame: 2 years
Mortality
* all cause death * sudden cardiac death * cardiovascular death * transplantation
Time frame: 2 years
New York Heart Association (NYHA) Functional Classification
The New York Heart Association (NYHA) functional classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.
Time frame: 2 years
Minnesota Living with Heart Failure Questionnaire
Minnesota living with heart failure questionnaire is a validated patient-oriented measure of the adverse effects of heart failure on a patient's life.
Time frame: 2 years
Packer clinical composite score
The Packer clinical composite score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined using clinical outcomes (hospitalizations, death, heart transplant), heart failure status, and patient symptoms (defined by a higher New York Heart Association (NYHA) functional classification and quality of life measured using the Minnesota Living With Heart Failure Questionnaire). Each endpoint will be assessed at 6, 12, 18, and 24 months.
Time frame: 2 years
6 minute walk test
The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The test will be performed in group 1 before implantation and at 6 months control to evaluate response to intervention.
Time frame: 6 months
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