Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation

Previous randomized clinical trials with CRT provided evidence of an
improvement of HF symptoms, exercise capacity, quality of life and a relative
and absolute reduction in all-cause mortality. CRT has been included in the
official guidelines for the management of heart failure subjects. These
guidelines currently still recommend a QRS width of > 120ms as a criterion for
prescription of CRT. Results of more recent studies, however, indicate that the
QRS width alone is a weak marker for LV dyssynchrony and a poor guide to
treatment benefit for CRT. So far, only single center trials and a small
multi-center randomised controlled pilot study have been conducted evaluating
CRT in subjects with HF and narrow QRS. Thus, CRT treatment could be of
therapeutic benefit in the majority of HF patients with a narrow QRS width
(<120 ms), of whom up to 50% exhibit LV dyssynchrony.

The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy
(CRT) on mortality and morbidity of subjects with heart failure due to left
ventricular systolic dysfunction, already receiving optimized HF medication,
with a narrow QRS width (< 130 ms) and echocardiographic evidence of
ventricular dyssynchrony

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator,
Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D
system with ICD back-up enabled. Patients will be randomized to CRT=ON or
CRT=OFF.

Study Type: interventional
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization
Therapy (BIOTRONIK Lumax HF-T CRT-D)

All patients are indicated for an ICD and wil be implanted with a biventricular
ICD system (CRT-D: BIOTRONIK Lumax HF-T). All devices used are CE marked.
Potential risks for the patient related to this study include those typical of
a CRT-D system implant (more specifically the positioning of the left
ventricular electrode). CRT therapy will be randomised to CRT=ON and CRT=OFF
group. 50% of patients will not benefit from the left ventricular lead implant
whereas the other 50% have the potential to benefit from the CRT therapy.
Approximately 1 month after the randomisation the investigator will evaluate
the CRT-D system, the HF medication and perform a clinical evaluation on the HF
status. During a period of 24 months these investigations are repeated every 3
months. The HF treatment as described in the protocol is in accordance with the
current medical treatment of HF patients. Additionally there is: an
echocardiogram (at baseline, 6 and 12 month), 6 minute walk test (baseline and
at month 6, 12 and 24), BNP measurement (at baseline, 6 and 12 month) and a
MLHF questionnaire (baseline and at month 3, 6, 12, 18 and 24). After the 24
month visit the patient is requested to return every 3 months for standard
follow-up visits until the study is over.