Model 4396 Left Ventricular (LV) Lead Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | March 2009 |
| End Date: | August 2010 |
Model 4396 Left Ventricular 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 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.
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.
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 statistical power to show safety at one-month after implant. It also has
statistical power to show effectiveness at one-month and three-months after implant.
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. It also has
statistical power to show effectiveness at one-month and three-months after implant.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
20
sites
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