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NCT00356057 · ClinicalTrials.gov registry record · NA
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
A NA study, sponsored by Biotronik.
- Terminated
- Registry status
- NA
- Development phase
- 153
- Enrollment target
NCT00356057: Clinical Trial NA study, sponsored by Biotronik.
NCT00356057 is a NA study that was terminated before completion, run by Biotronik. The registered enrollment target is 153 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00356057, a NA study, was terminated before completion, sponsored by Biotronik.
- TERMINATED
- Registry status
- NA
- Development phase
- 153 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.
Primary Outcome
Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))
Interventions
- DEVICE Protos DR/CLS and Stratos LV CRT pacemakers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2004-12 |
| Est. Completion | 2008-06 |
| Phase | NA |
Why NCT00356057 stopped before completion
NCT00356057 is an interventional study that assigns participants to a tested intervention. The registered 153 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 (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Protos DR/CLS and Stratos LV CRT pacemakers is the first listed.
NCT00356057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00356057 about?
NCT00356057 is a clinical study titled "Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace". The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.
What is the current status of trial NCT00356057?
This trial is currently terminated. It is a NA study. The enrollment target is 153 participants. The study started on 2004-12. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00356057?
The interventions under investigation include: Protos DR/CLS and Stratos LV CRT pacemakers (DEVICE).
Who is sponsoring clinical trial NCT00356057?
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 NCT00356057's enrollment target sits among peer trials
153 656th of 2000 higher than 1,343 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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