Model 4296 Left Ventricular (LV) Lead Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Model 4296 LV Lead

Non-randomized study

Group Type EXPERIMENTAL

Pacing Lead (Model 4296 LV Lead)

Intervention Type DEVICE

Implant and follow-up of study device

Interventions

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Pacing Lead (Model 4296 LV Lead)

Implant and follow-up of study device

Intervention Type DEVICE

Eligibility Criteria

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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
* Unable to tolerate urgent thoracotomy

Eligible Sex

ALL

Accepts Healthy Volunteers

No