Heart Failure Clinical Trial
Official title:
ALternate Site Cardiac ReSYNChronization Study
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective,
non-randomized, multi-national clinical investigation.
The purpose of this clinical investigation is to evaluate the safety and performance of the
investigational atrial transseptal endocardial LV lead delivery system and the implant
procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a
superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in
the Left Ventricle.
Cardiac resynchronization therapy (CRT) reduces mortality and the risk of heart failure
decompensation and improves quality of life in indicated patients. However, many do not
benefit due to failure to deliver the left ventricular (LV) lead via coronary sinus (5-10%)
or lack of symptomatic improvement (30-40%).
The purpose of the ALSYNC Study was to evaluate the feasibility and safety of LV endocardial
(LVE) pacing using a Model 3830 lead implanted by a novel pectoral atrial transseptal lead
delivery system.
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