Heart Failure Clinical Trial
Official title:
Quadripolar Leads for the Management of Heart Failure Patients in the Middle East
Heart failure is the most rapidly growing cardiovascular condition in developed countries.
Despite advances in medical therapy, patients with heart failure are at high risk for death
and hospitalization. Cardiac Resynchronization Therapy - defibrillators (CRT-D) are an
effective treatment for heart failure.
Despite the high success rate of a CRT-D implant, there is a possibility of 10% that the LV
lead cannot be implanted in patients undergoing a trans-venous system implantation. In this
case, the patients may undergo multiple procedures before a lead is successfully implanted.
These implant failures are not due to patient selection but rather to patients heart anatomy
leading to lead stability problems, phrenic nerve stimulation (also called diaphragmatic
stimulation) and poor electrical measurements.
The phrenic nerve is not part of the heart but runs near to this area on the way to a large
muscle, called diaphragm, which separates the lung space from the space containing stomach,
liver, kidneys and other internal organs in the abdomen. If the lead electrode is close to
this nerve, it can cause a small part of it to contract giving you an uncomfortable
hiccupping sensation.
In many patients, phrenic nerve stimulation is not identified until after the implant
procedure when movement and postural changes bring the LV lead into closer contact with the
phrenic nerve.
The investigation is performed to demonstrate the equality of performance of two different
modalities of optimization of the implanted device and Quartet lead, Empirical (anatomical)
optimization and Right Ventricle Left Ventricle (RVLV) conduction delay optimization.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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