Model 20066 LV Lead Study

Several randomized, controlled clinical trials (including MIRACLE, MIRACLE-ICD,
CONTAK-CD, MUSTIC, PATH-CHF, COMPANION, MADIT CRT, and CARE-HF) have
demonstrated the benefit of cardiac resynchronization therapy (CRT) among
patients with moderate to severe heart failure (HF) with a prolonged QRS
duration and a depressed Left Ventricular (LV) function. This therapy is
delivered by a cardiac resynchronization system that consists of three pacing
leads and an implantable pulse generator or implantable cardioverter
defibrillator device.
Various lead models are required to suit the various sizes and shapes of
patients* cardiac venous anatomy and implanting physician preferences. Despite
advancements in Left Ventricle (LV) lead technology, the majority of
post-implant invasive interventions to the Cardiac Resynchronization (CR)
system are required due to the LV lead. In some patients, the LV lead requires
revision or replacement due to an increase in pacing thresholds, dislodgement,
phrenic nerve stimulation or lack of patient response to CR therapy. During the
Attain Ability Model 4196 clinical study there were a total of 170 patients
implanted and nine (9) patients had a LV lead related complication. All nine
lead related complications occurred within 36 days of implant and were due to
lead dislodgements.
The Model 20066 lead is a derivative of the market released Attain® Ability*
Model 4196 lead and has been designed to reduce the occurrence of LV lead
dislodgments. The Model 20066 lead has a small side helix that will allow
physicians to securely place the lead in an area that was previously unstable
with a non-active fixation LV lead. This lead may allow the implanting
physician greater flexibility to place the lead in their desired location which
has the potential to improve CRT response.

The purpose of this study is to evaluate the implant procedure and feasibility
of the Model 20066 LV lead.
The proposed Model 20066 study will provide data to assess the safety and
feasibility of the Model 20066 fixation concept. It is also expected that this
lead will reduce LV lead related complications and more specifically reduce the
occurrence of LV lead dislodgments.

It is expected that when 30 patients are followed until their one month visit,
Medtronic has collected sufficient data to determine whether it is feasible to
use the Model 20066 fixation technology for the future LV guidance platforms.
Incidence of Model 20066 guidance related complications will be assessed
against a benchmark interest rate seen with the 4196 guideline LV (9 out of 170
= 5.3%). If 5 Model 20066 guidance related complications within the first month
of follow-up investigations, participation will be suspended and evaluated by
the research team. The study team will consult with the researchers to
determine whether the Model 20066 guide complications were related to the
guideline, implantation procedure training, installation guide or other
unforeseen factor. Based on this consultation with the researchers a decision
will be made again to continue participation or to conclude the study.

The risks associated with this study are expected to be similar to other LV
lead implants and the benefit of increased lead stability out weight the risk
of the known LV related complications.