TerminatedInterventionalNot ApplicableUpdated Oct 26, 2016
Model 20105 Lead Study
Model 20105 Lead Study
ClinicalTrials.gov ID
NCT02301429
Lead Sponsor
Medtronic BRCINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Not Applicable
Enrollment
16Actual
Last Update Posted
Oct 26, 2016Estimated
Start Date
Nov 2014
Primary Completion Date
Jul 2016Actual
Completion Date
Jul 2016Actual
Official Title
Model 20105 Lead Study
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.
Sick Sinus Node Syndrome
Model 20105
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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