Model 20105 Lead Study

Single passive fixation leads have been available for right sided pacing since
the 1990s and still are widely used today. The advantages of a single pass lead
are twofold: first, one can achieve atrial synchronous pacing with just one
lead, meaning less prosthetic material and a shorter implant time and, second,
because there is no atrial lead to pass, it lessens the chances of atrial lead
dislodgement and atrial lead perforation.
However, there are disadvantage, first, it can only sense the atrium not pace
the atrium and, second, the ventricular electrode affixes most readily in the
right ventricle (RV) apex, today considered a less-than-optimal pacing site and
third, the lead passes through the tricuspid valve, worsening effects of
tricuspid regurgitation and contraindicating in patients with mechanical heart
valves.
To overcome these limitations Medtronic has designed and manufactured Model
20105 lead which allows doing trans-venous sensing and pacing the left atrium
(LA) and the left ventricle (LV). Thus the lead works as a left-sided single
pass DDD lead (LV-DDD). The lead has two proximal electrodes for LA pacing and
sensing and two distal ventricular electrodes placed in the coronary veins of
the LV, thought to be a more physiologic site for pacing than the RV apex and
the lead does not pass through the tricuspid valve. Since model 20105 is a left
sided pacing lead it can be used for Brady pacing as well as Cardiac
Resynchronization Therapy (CRT) applications. In CRT this lead may benefit in
better optimization of timing between left atrial emptying and left ventricular
filling as well as ejection.
The safety and feasibility of active fixation in a coronary vein with side
helix is already studied in a human clinical study. The 20105 lead used side
helix technology with lead body design closest to the market released Medtronic
Attain Ability Model 4196 lead and Medtronic Attain Performa® Quadripolar Lead.
No human clinical studies have previously been conducted with Model 20105
single pass lead. The risks and side effects associated with the implant of the
Model 20105 Lead are the same as the implantation of any other market-released
left ventricular lead.

The purpose of this study is to evaluate the implant procedure and feasibility
of the Model 20105 lead.

Model 20105 study is a prospective, multi-center, research study involving
approximately 5 centers in up to 4 countries. Enrolled subjects will be
followed at baseline, implant, pre-discharge, 1 month, 3 month and 6 month
follow up.

At baseline- ECG
Implant - holter/ venogram
PH - Echocardiogram/ ECG
1 mnd - geen extra handeling
3 mnd - holter
6 mnd - Echocardiogram

The Model 20105 lead has a little helix to fix the lead to the wall of your
vein. There may be damage to the vein wall caused by the helix.

There is a potential risk that the Model 20105 lead is not sensing correctly
the atrium or that it requires a high energy to stimulate the atrial chamber of
your heart. This may cause you to feel a change in heartbeats or to consume
faster the battery of the device.

The risks and side effects associated with the implant of the Model 20105 Lead
are the same as the implantation of any other market-released left ventricular
lead.