Model 4296 Left Ventricular Lead Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 90
- Primary Endpoint
- Number of Participants With Left Ventricular (LV)Lead Related Complications
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
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.