Cardioblate Closure Device Closed Thorax Trial:An Evaluation of the Cardioblate® Closure* Device in Facilitating Occlusion of the Left Atrial Appendage in Closed Thorax Surgeries

The left atrial appendage (LAA) is a long, tubular, hooked structure which is
usually crenellated and has a narrow junction with the venous component of the
atrium. In patients with cardiac failure and especially atrial fibrilation
(AF), there is an increase risk of the formation thrombi in the LAA. These
thrombi pose a risk for strokes and other thromboembolic evenets.
Patients at risk are typically maintained on anticoagulation therapy (warfarin)
to reduce the risk of stroke. Warfarin studies have shown some risks to
include fatal or nonfatal hemorrhage from tissue or organ, bleeding, and
necrosis of the skin and other tissues.The concept of removing the LAA in order
to prevent stroke dates back to the earliest mitral valvotomy procedure for
rheumatic mitral stenosis in the 1930*s. The LAA is then occluded during a
concommitant surgery for an other indication. Usually sutures or stappler
device are used. These method have proven their effectivity but are difficult
to perform dirng minmal invastive surgery. Medtronic has developed the
Cardioblate closure device in order to occlude the LAA in a safe and easy
manner also during minimal invasive surgery.

This clinical study will evaluate the safety and performance of the Closure
device to occlude the LAA during minimal invasive surgery.
The objectives of the study are:
• To evaluate the ability of the Cardioblate® Closure* device to occlude the
LAA during Closed Thorax surgical procedures at 3 months post-surgery as
measured by a CT scan.
• To evaluate the composite incidence rate of device-related adverse events
during device placement and within 30 days post-surgery or hospital discharge,
whichever is longer;
• To evaluate successful placement of the band where successful placement is
defined as 95% of the devices being properly placed onto the base of LAA (<10
mm of residual stump proximal to the band) at the time of the procedure;

Prospective, non-randomised, multi-center post market release study.

In the participating patients, the left atrial appendage (LAA) will be occluded
using the Cardioblate® Closure* Device, during minimally invasive cardiac
surgery. The occlusion of the LAA will be concomitant to an other cardiac
procedure (ea heart valve replacement, surgical ablation, coronary artery
bypass grafting). In order to evaluate successful band placement and occlusion
of the LAA, a trans-esophagus echocardiogram will be performed during surgery.
After the surgical procedure the patient is scheduled for 3 follow-up visits.
During the follow-up visits the following data will be collected:
- Adverse events
- NYHA classification
- CHADS score
- Anticoagulation medication status
At the 3 month follow-up visit, a CT scan will be performed to asses the blood
communication between the LA and the LAA.

Study subjects must be informed of all known potential side effects and
complications associated with study treatment and evaluations prior to
enrollment in the study. The benefits of the conduct of this study outweigh the
potential risks for the participants.
Potential Risks
Risks associated with the Closure device are not yet known. Potential risks
associated with occlusion of the LAA are, but not limited to:
• LAA tear requiring surgical repair
• Bleeding requiring surgical re-operation intervention
• Unintentional tissue damage requiring surgical intervention
• Re-operation due to band displacement
• Incomplete occlusion of the LAA
Standard risks associated with any cardiac surgery being performed in
conjunction with LAA occlusion should be discussed with the subject in detail
by the Investigator. Identified risks associated with cardiac surgery are, but
not limited to:
• Stroke
• Heart attack
• Graft failure
• Loss of life
• Serious bleeding
• Heart or lung problems
• Kidney failure
• Allergic reaction to medication
• Nerve or organ damage
Risks associated with the TEE
• Tissue damage of the esophagus and the troth
• Allergic reaction to lubricant
The CT scan poses almost no risk to subjects. Potential risks associated with a
CT scan are:
• Risks associated with heavy sedation, if used
• Allergic reaction to contrast
• Risk of cancer from radiation
The risks associated with the CT scan are very low and will not provide an
additional health risk.
Based on a review send to the TUV (Clinical Evidence Report AF007/D02987) of
comparable devices, a list of device-related Adverse Events including their
incidence rates is provided in table 3.
The treatment in this study will not interfere with other treatments or medical
interventions as subjects with the risk of such possible interactions are
excluded by the exclusion criteria.

Incidence rates of device related AE*s of comparable products
Adverse Event Incidence rate %
LAA tears 4.29
Bleeding 0.23
Tissue damage needing surgical repair 0.0

Risk minimization
Subjects are required to have a need for cardiac surgery other than closure of
the LAA. The majority of risk for these subjects will be in undergoing closed
thorax cardiac surgery for the concomitant procedure. The additional time
required for Closure band placement and the potential adverse events related to
this procedure are minimal in comparison to the concomitant procedure. These
risks will be minimized by providing adequate training to the cardiac surgeon
performing the procedure.

Potential benefits associated with the procedure/study
Participation in this study is voluntary. Although this study is not intended
to demonstrate a reduction in thromboemboli for subjects with AF, it has been
studied that occlusion or removal of the LAA may decrease thrombus formation in
the LA in some subjects. Subjects may or may not benefit from this procedure.