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NCT00395642 · ClinicalTrials.gov registry record · Phase 4
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
A Phase 4 study, sponsored by Biotronik.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT00395642: Completed Phase 4 study, sponsored by Biotronik.
NCT00395642 is a Phase 4 study that has completed, run by Biotronik. The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00395642, a Phase 4 study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and define endpoints for a larger randomized study. The study will assess the HM-parameter trends correlation with daily weight and blood pressure changes. The patient compliance rate of the two different telemonitoring systems (HM \& ETM) will also be evaluated.
Primary Outcome
Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for
Interventions
- DEVICE Kronos LV-T, Lumax HF-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
What the finished NCT00395642 record still lists
NCT00395642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Kronos LV-T, Lumax HF-T is the first listed.
NCT00395642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00395642 about?
NCT00395642 is a clinical study titled "TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D". This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defib...
What is the current status of trial NCT00395642?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2006-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00395642?
The interventions under investigation include: Kronos LV-T, Lumax HF-T (DEVICE).
Who is sponsoring clinical trial NCT00395642?
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 NCT00395642's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 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
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