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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Foothills Hospital
Calgary, Alberta, Canada
London Health Sciences
London, Ontario, Canada
Quebec Heart Institute
Ste-Foy, Quebec, Canada
Change in end systolic volume plus reduction in symptoms
Time frame: over 12 months
Minnesota Living with Heart Failure score.
Time frame: Change over 12 months
Short form thirty six score.
Time frame: Change over 12 months
Specific Activity Scale score.
Time frame: Change over 12 months
New York Heart Association class.
Time frame: Change over 12 months
Six minute walk distance.
Time frame: Change over 12 months
LV volumes.
Time frame: Change over 12 months
N-terminal pro-B-type natriuretic peptide.
Time frame: Change over 12 months
Mortality
Time frame: Study duration
Hospitalization
Time frame: Study duration
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