Trials / Completed
CompletedNCT00853593
Model 4396 Left Ventricular (LV) Lead Study
Model 4396 Left Ventricular Lead Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pacing Lead | implant and follow-up of study device |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2009-07-01
- Completion
- 2010-08-01
- First posted
- 2009-03-02
- Last updated
- 2019-02-18
- Results posted
- 2011-12-05
Locations
31 sites across 8 countries: United States, Australia, Austria, Canada, Denmark, France, Italy, Saudi Arabia
Source: ClinicalTrials.gov record NCT00853593. Inclusion in this directory is not an endorsement.