Heart Failure
Conditions
Keywords
Cardiac resynchronization therapy, Echocardiography, Cardiac computed tomography
Brief summary
For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment. New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based optimal placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.
Interventions
OTHERImaging guided LV lead positioning
LV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate optimal cardiac vein segment is then chosen using the CT images.
Sponsors
Crafoord Foundation
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy. * Wide QRS ≥ 120 milliseconds on standard ECG. * LV systolic dysfunction (EF ≤ 35%). * Written informed consent. * Accepted for CRT-P or CRT-D treatment
Exclusion criteria
* Life expectancy \< 12 months. * Recent myocardial infarction (\< 3 months). * Significant valve disease * Chronic atrial fibrillation * Pregnancy * Severely impaired renal function (estimated glomerular filtration rate (eGFR) \< 30 ml/min) * Unable to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive response to CRT treatment | 6 months | The primary efficacy endpoint will evaluate the effect of echocardiography and cardiac CT guided placement of the left ventricular lead vs standard care (i.e. position of the left ventricular lead at the discretion of the treating physician). Number of patients with positive response to CRT (YES or NO). A positive response is defined as survival in combination with either a reduction in end systolic left ventricular volume ≥ 15% by echocardiography (volume responder) and / or improvement ≥ 1 NYHA class and ≥10% improvement in 6 minute hall walk test (clinical responder). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular systolic function | 6 months | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in LV ejection fraction |
| MRI left ventricular dyssynchrony | 6 months | Evaluate if MRI dyssynchroni evaluation has incremental value over echocardiography alone for predicting the effect of cardiac resynchronization therapy. |
| Heart failure morbidity | 6 months 2 years and 5 years | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to hospitalisation for worsening of heart failure |
| Morbidity and mortality | 6 months 2 years and 5 years | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to a composite endpoint of all cause mortality and hospitalisation for worsening of heart failure (2 years and 5 years). |
| Mortality | 6 months, 2 years and 5 years | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to all cause mortality |
| Response to CRT (on-treatment analysis) | 6 months | Evaluate the effect of optimal LV placement (post hoc analysis of both groups) versus non-optimal LV lead placement. Optimal lead placement is defined as pacing from a viable segment with the latest mechanical activation (by myocardial strain measurement). Outcome measure is the same as in the primary outcome measure. |
| Ventricular tachycardia | 6 months 2 years and 5 years | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to number of treated ventricular tachycardia episodes |
| Quality of life | 6 months 2 years 5 years | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in the Minnesota Living with heart failure Quality of Life questionnaire |
| Myocardial viability | Peroperative | Evaluate the concordance in viability assessment using myocardial strain evaluation (echocardiography) compared to cardiac MRI. |
| Biochemical markers of heart failure | 6 months | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in blood natriuretic peptide (BNP) levels |
| Left ventricular diastolic dimension | 6 months | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in left ventricular diastolic dimension |
| Left ventricular dyssynchrony | 6 months | Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to echocardiography measured changes in LV dyssynchrony |
Countries
Sweden
Outcome results
None listed