Model 20105 Lead Study
This trial is active, not recruiting.
|Condition||sick sinus node syndrome|
|Start date||November 2014|
|End date||July 2016|
|Trial size||16 participants|
|Trial identifier||NCT02301429, LV DDD|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|London, Canada||London Teaching Hospital||no longer recruiting|
|Delft, Netherlands||Reinier de Graaf Hospital||no longer recruiting|
|Singapore, Singapore||NUHCS, National University Hospital||no longer recruiting|
|Johannesburg, South Africa||Milpark hospital||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Receiving the model 20105 Lead
All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.
time frame: 1 month
Male or female participants at least 18 years old.
- 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
- 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
|Official title||Model 20105 Lead Study|
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