Model 4296 Left Ventricular (LV) Lead Study

Medtronic

Status

Completed

Conditions

Heart Failure

Treatments

Device: Pacing Lead (Model 4296 LV Lead)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00927251

4296

Details and patient eligibility

About

This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Full description

This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.

Enrollment

90 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
On optimal medical treatment according to investigator opinion
Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
Patient consent
Geographically stable

Exclusion criteria

Left Ventricular (LV) lead implant attempt in last 30 days
Unstable angina or acute myocardial infarction (MI) in past 30 days
Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
Contraindicated for transvenous pacing
Heart transplant
Contraindicated for less than 1 milligram (mg) dexamethasone acetate
Enrolled or intends to participate in concurrent drug and/or device study which would confound results
Life expectancy shorter than duration of the study
Exclusion criteria required by local law
Unable to tolerate urgent thoracotomy