Status:
COMPLETED
Model 4396 Left Ventricular (LV) Lead Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 and effective. Using a lead on the left side of the heart has been shown to p...
Detailed Description
This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has sta...
Eligibility Criteria
Inclusion
- CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable
Exclusion
- 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 3 months, contraindicated for transvenous pacing, heart transplant
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00853593
Start Date
March 1 2009
End Date
August 1 2010
Last Update
February 18 2019
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
Pasadena, California, United States
2
Sacramento, California, United States
3
Atlantis, Florida, United States
4
Atlanta, Georgia, United States