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NCT00508391 · ClinicalTrials.gov registry record · Phase 2
Interventricular Delay of Lumax HF-T for Heart Failure
A Phase 2 study, sponsored by Biotronik.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
NCT00508391: Completed Phase 2 study, sponsored by Biotronik.
NCT00508391 is a Phase 2 study that has completed, run by Biotronik. The registered enrollment target is 122 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00508391, a Phase 2 study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax HF-T with simultaneous biventricular pacing (SIM) in patients with heart failure requiring cardiac resynchronization therapy.
Primary Outcome
The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified "not worsened" if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used f
Interventions
- DEVICE Optimized interventricular delay biventricular pacing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00508391 record still lists
NCT00508391 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Optimized interventricular delay biventricular pacing is the first listed.
NCT00508391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00508391 about?
NCT00508391 is a clinical study titled "Interventricular Delay of Lumax HF-T for Heart Failure". The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax HF-T with simultaneous biventricular pacing (SIM) in patients with heart failure requiring cardiac resynchronizatio...
What is the current status of trial NCT00508391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2007-07. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00508391?
The interventions under investigation include: Optimized interventricular delay biventricular pacing (DEVICE).
Who is sponsoring clinical trial NCT00508391?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00508391's enrollment target sits among peer trials
122 565th of 2000 higher than 1,434 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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