Model 20066 Left Ventricular (LV) Lead Study

This is an interventional treatment trial for Heart Failure Read More

Inclusion Criteria:

• Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy
• Patient has signed and dated the study-specific informed consent form
• Patient is 18 years of age or older
• Patient is expected to remain available for follow-ups at the investigational center
• Patient is willing and able to comply with protocol

Exclusion Criteria:

• Patient has a previous complete atrial based biventricular CRT system
• Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
• Patient has known coronary venous vasculature that is inadequate for lead placement
• Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
• Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
• Patient has chronic (permanent) atrial arrhythmias
• Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
• Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
• Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
• Patient has a terminal illness and is not expected to survive more than three months
• Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc).
• Patient is unable to tolerate an urgent thoracotomy