HF Patient Clinical Trial
Official title:
Optimization of Coronary Sinus Lead Placement Targeted to the Longest Right-to-Left Delay
This study is a prospective, multi-center, physician-initiated study, with intra-center
control arm of patients with advanced heart failure undergoing cardiac resynchronization
therapy (CRT) with or without defibrillator therapy.
The purpose of this study is to verify whether optimizing the left ventricular lead position
at implantation with the pacing cathode corresponding to the longest RV-to-LV electrical
delay may result in a better patient outcome. The RV-to-LV electrical delay will be evaluated
with RLD value (ms). RLD is the distance between the Right Ventricular pacing marker (VP) and
the maximum peak (or the first maximum peak in case of two equally tall peaks) of the LV
bipolar deflection.
This study is a prospective, multi-center, physician-initiated study, with intra-center
control arm of patients with advanced heart failure undergoing cardiac resynchronization
therapy (CRT) with or without defibrillator therapy.
Approximately 300 patients will be included in the study and followed-up for 6 months.
Patients recruitment will consist of two sequential phases:
Phase 1 - Conventional CS lead placement (Conventional subgroup). The first 100 patients will
be implanted with a CRT device with or without defibrillator (P/D) as per standard clinical
practice, without CS lead pacing specific optimization. In these patients RLD is measured
blind to implanting physician who will place CS lead according to his/her clinical practice.
Since these patients follow strictly standard clinical practice, their implantation data can
be collected prospectively or even retrospectively when available.
Phase 2 - Targeted CS lead placement (RLD subgroup). In the second 200 patients CS placement
will be guided by RLD measurement. Physician will place the CS lead in the site of longest
RLD with a stable and acceptable pacing threshold.
;