Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Part of paid clinical trials in Falls Church, Virginia.
- Sponsor
- Inova Health Care Services
- Study ID
- NCT04419480
- Status
- Recruiting
Conditions
- Ambulatory Hemodynamic Monitoring
- Cardiogenic Shock
- Heart Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization — DEVICEImplantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.
Study Details
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Key Dates
- Start date
- Dec 31, 2020
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CardioMEMS Implant GroupFollowing enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.
- No Intervention: Non-CardioMEMS Implant GroupFollowing enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.
Primary Outcome Measure
Hierarchical primary endpoint [ Time Frame: 6 months ]
Central Contacts
- Shashank Sinha, MD MSc7037764001
- Bhruga Shah, MPH17037762828
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | Shashank Sinha, MD MSc (PRINCIPAL_INVESTIGATOR) |
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