Trials / Active Not Recruiting
Active Not RecruitingNCT04790344
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 525 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Detailed description
The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Investigational LUX-Dx ICM Implant | All subject will receive an investigational version of the LUX-Dx ICM device. |
Timeline
- Start date
- 2021-03-20
- Primary completion
- 2026-05-01
- Completion
- 2026-06-01
- First posted
- 2021-03-10
- Last updated
- 2026-04-17
Locations
56 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04790344. Inclusion in this directory is not an endorsement.