Model 20105 Lead Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.

Official Title
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Model 20105 Lead Study

Conditions
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Sick Sinus Node Syndrome

Intervention / Treatment
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* Device: Model 20105


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker) Subject has signed and dated the study-specific informed consent form Subject is 18 years of age or older Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study Exclusion Criteria: Subject is indicated for BiV pacemaker or ICD Subject is pacing dependent Subject has a previous Pacemaker System Subject has known coronary venous vasculature that is inadequate for lead placement Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months Subject is not in sinus rhythm at implant Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study) Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure Subject is contraindicated for <1mg dexamethasone acetate Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study Subject has a terminal illness and is not expected to survive more than 6 months Subject is a pregnant woman or woman of childbearing potential not on adequate birth control. Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators. Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study Subject meets exclusion criteria required by local law. Subject is unable to tolerate an urgent thoracotomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Model 20105<br>Receiving the model 20105 Lead | Device: Model 20105<br>* implant and follow-up of study device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. | All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed. | 1 month |