Status:
COMPLETED
Model 4296 Left Ventricular (LV) Lead Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
Phase:
NA
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 imp...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00927251
Start Date
June 1 2009
End Date
February 1 2010
Last Update
February 18 2019
Active Locations (16)
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1
Linz, Austria
2
Vienna, Austria
3
Oulu, Finland
4
Bad Rothenfelde, Germany