510198
Last Update Posted: 2019-04-10
Recruiting has ended
All Genders accepted | 18 Years + |
120 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that records information about the heart that doctors can use to help treat their heart disease) combined with standard treatment methods (Access Group) to patients whose heart failure is managed by standard treatment methods only (Control Group). This comparison will show if the additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are first admitted to hospital for heart failure or delays the time to death.
PRECEDE-HF was a prospective, multi-center, randomized, investigational device exemption (IDE) clinical study. The purpose of this study was to collect data required to determine whether the use of Cardiac Compass including OptiVol Fluid Status Monitoring with standard clinical assessment ("Access Arm") will result in a longer time to first heart failure hospitalization or death compared to standard clinical assessment alone ("Control Arm") and to support the approval of the following device features:
- OptiVol Alert (audible and home monitor alerts) for use in Medtronic devices
- SentryCheck™ Monitor
- OptiVol Alert Suspend (OptiVol enhancement)
- OptiVol Reference Impedance Adjustment (OptiVol enhancement)
Eligibility
Relevant conditions:
Congestive Heart Failure
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov