Model 20105 Lead Study

Medtronic

Status

Terminated

Conditions

Sick Sinus Node Syndrome

Treatments

Device: Model 20105

Study type

Interventional

Funder types

Industry

Identifiers

NCT02301429

LV DDD

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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