Status:
TERMINATED
Model 20105 Lead Study
Lead Sponsor:
Medtronic BRC
Conditions:
Sick Sinus Node Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02301429
Start Date
November 1 2014
End Date
July 1 2016
Last Update
October 26 2016
Active Locations (4)
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1
London Teaching Hospital
London, Canada
2
Reinier de Graaf Hospital
Delft, Netherlands
3
NUHCS, National University Hospital
Singapore, Singapore
4
Milpark hospital
Johannesburg, South Africa