Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00559988 · ClinicalTrials.gov registry record · Phase 4
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
A Phase 4 study, sponsored by Biotronik.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2,718
- Enrollment target
NCT00559988: Clinical Trial Phase 4 study, sponsored by Biotronik.
NCT00559988 is a Phase 4 study that was terminated before completion, run by Biotronik. The registered enrollment target is 2,718 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (425% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00559988, a Phase 4 study, was terminated before completion, sponsored by Biotronik.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2,718 participants
- Enrollment target
Study Summary
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.
Primary Outcome
The primary endpoint is to demonstrate whether early detection of atrial arrhythmias based on BIOTRONIK Home Monitoring technology combined with a predefined anticoagulation plan in the Home Monitoring Guided OAC group is superior to the Physician-Directed OAC group reflecting conventional care and physician directed treatment of AF in terms of risk reduction of the primary composite endpoint including stroke, systemic embolism, and major bleeding events.
Interventions
- DRUG Home Monitoring Guided OAC
- DRUG Physician-Directed OAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,718 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
Why NCT00559988 stopped before completion
NCT00559988 is an interventional study that assigns participants to a tested intervention. Its 2,718 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (425% higher).
The record links to 0 conditions, and to 2 interventions - of which Home Monitoring Guided OAC is the first listed.
NCT00559988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00559988 about?
NCT00559988 is a clinical study titled "Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk". The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrilla...
What is the current status of trial NCT00559988?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2,718 participants. The study started on 2008-02. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00559988?
The interventions under investigation include: Home Monitoring Guided OAC (DRUG), Physician-Directed OAC (DRUG).
Who is sponsoring clinical trial NCT00559988?
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 NCT00559988's enrollment target sits among peer trials
2,718 26th of 2000 higher than 1,975 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06085833 · 2,706 participants · NA
ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions
- NCT04073420 · 2,700 participants
Medtronic Cardiac Surgery PMCF Registry
- NCT05125939 · 2,700 participants
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
- NCT05586776 · 2,700 participants · Phase 4
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia