Trials / Completed
CompletedNCT00927251
Model 4296 Left Ventricular (LV) Lead Study
Model 4296 Left Ventricular Lead Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- —
- 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. 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 trial. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pacing Lead (Model 4296 LV Lead) | Implant and follow-up of study device |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-12-01
- Completion
- 2010-02-01
- First posted
- 2009-06-24
- Last updated
- 2019-02-18
- Results posted
- 2010-12-29
Locations
16 sites across 8 countries: Austria, Finland, Germany, India, Italy, Netherlands, Norway, Slovakia
Source: ClinicalTrials.gov record NCT00927251. Inclusion in this directory is not an endorsement.