Trials / Completed
CompletedNCT01090349
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits. This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of an ICD/CRT-D device | The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation. |
| DEVICE | Merlin.NET PCN | The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-04-01
- Completion
- 2014-04-01
- First posted
- 2010-03-19
- Last updated
- 2019-02-04
Locations
2 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT01090349. Inclusion in this directory is not an endorsement.