Model 4296 Left Ventricular (LV) Lead Study

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Pacing Lead (Model 4296 LV Lead)

• Registration Number: NCT00927251
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Primary Completion: 2009-12
• Study Completion: 2010-02
• Results First Submitted: 2010-06-07
• Results First Submitted QC: 2010-12-01
• Results First Posted: 2010-12-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Model 4296 LV Lead	Pacing Lead (Model 4296 LV Lead)	Non-randomized study

Primary Outcome Measures

Name	Time	Method
Number of Participants With Left Ventricular (LV)Lead Related Complications	Implant to one-month post implant	A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.