Model 4296 Left Ventricular (LV) Lead Study

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linz, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacing Lead (Model 4296 LV Lead)

Device

Implant and follow-up of study device

Primary outcomes

Number of Participants With Left Ventricular (LV)Lead Related Complications

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Model 4296 Left Ventricular Lead Study

Acronym: 4296

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Jun 24, 2009
Registry last updated: Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed