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NCT00853593 · ClinicalTrials.gov registry record · NA
Model 4396 Left Ventricular (LV) Lead Study
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
NCT00853593: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00853593 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 197 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853593, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
Study 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.
Primary Outcome
A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the s
Interventions
- DEVICE Pacing Lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-08 |
| Phase | NA |
What the finished NCT00853593 record still lists
NCT00853593 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Pacing Lead is the first listed.
NCT00853593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853593 about?
NCT00853593 is a clinical study titled "Model 4396 Left Ventricular (LV) 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 ch...
What is the current status of trial NCT00853593?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2009-03. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00853593?
The interventions under investigation include: Pacing Lead (DEVICE).
Who is sponsoring clinical trial NCT00853593?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853593's enrollment target sits among peer trials
197 567th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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