Model 20066 Left Ventricular (LV) Lead Study

Medtronic

Status and phase

Completed

Phase 1

Conditions

Heart Failure

Treatments

Device: Pacing Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT01365234

Model 20066

Details and patient eligibility

About

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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