Model 4396 Left Ventricular (LV) Lead Study

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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 potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Key facts

Study ID

NCT00853593

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

197

Starts

2009-03-01

Expected to finish

2010-08-01

Last updated by the study team

2019-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Pasadena, California, United States
• Study site — Sacramento, California, United States
• Study site — Atlantis, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Hinsdale, Illinois, United States
• Study site — Davenport, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Saint Louis Park, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Liverpool, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — York, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Morgantown, West Virginia, United States
• Study site — Bendigo, Australia
• Study site — Linz, Austria
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Newmarket, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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