Model 20105 Lead Study

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Model 20105	Model 20105	Receiving the model 20105 Lead

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (4): Milpark hospital
🇿🇦
Johannesburg, South Africa
Reinier de Graaf Hospital
🇳🇱
Delft, Netherlands
London Teaching Hospital
🇨🇦
London, Canada
NUHCS, National University Hospital
🇸🇬
Singapore, Singapore