Heart Failure, Congestive Clinical Trial
Official title:
Investigating Non-response to Cardiac Resynchronization: Evaluation of Methods to Eliminate Non-response & Target Appropriate Lead Location (INCREMENTAL).
Identifying & optimizing strategies to reduce the burden of heart failure is vital. Despite
advances in pharmacotherapy, patients with heart failure are at high risk for death &
hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical
activity, improves cardiac output & reduces HF symptoms. However, ~50% of patients do not
clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an
important reason for non-response.
This study will assess whether targeted LV lead placement will result in an increased
probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.
Background. Identifying & optimizing strategies to reduce the burden of heart failure (HF)
is vital. Despite advances in pharmacotherapy, patients with HF are at high risk for death &
hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular
contraction that results in paradoxical septal motion, further impairing left ventricular
(LV) function & HF progression. Cardiac resynchronization therapy (CRT) synchronizes
ventricular mechanical activity, improves cardiac output & reduces HF symptoms. However,
~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead
appears to be an important reason for non-response.
Screening. Mechanical synchrony is vitally important in optimizing CRT response. Patients
will be pre-screened with echocardiograms (echo) & CRT provided to only those with
dyssynchrony. The predicted rate of CRT response in patients pre-screened for dyssynchrony
is estimated at 65%.
CRT response. The combined use of a valid & simple measure of functional capacity with a
reproducible measure of LV volume is optimal in identifying CRT responders. These outcomes
will be assessed using the Specific Activity Scale & radionuclide angiography (RNA),
respectively.
Primary hypothesis. Targeted LV lead placement will result in an increased probability of
CRT response at 52 weeks vs. usual (lateral wall) lead placement. CRT response will be
defined as ≥ 10% relative reduction in LV end systolic volume & ≥ 1 Specific Activity Scale
class improvement.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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