Sick Sinus Node Syndrome Clinical Trial
Official title:
Model 20105 Lead Study
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.
| Status | Active, not recruiting |
| Enrollment | 16 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| 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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | London Teaching Hospital | London | |
| Netherlands | Reinier de Graaf Hospital | Delft | |
| Singapore | NUHCS, National University Hospital | Singapore | |
| South Africa | Milpark hospital | Johannesburg |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic BRC |
Canada, Netherlands, Singapore, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |