Model 4396 Left Ventricular (LV) Lead Study

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Pacing Lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853593

116

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 and effective. 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. 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. It also has statistical power to show effectiveness at one-month and three-months after implant.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable

Exclusion criteria

• 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 3 months, contraindicated for transvenous pacing, heart transplant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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197 participants in 1 patient group

Model 4396 LV Lead

Experimental group

Description:

Non-randomized study.

Treatment:

Device: Pacing Lead