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

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 — DEVICE
    Implantation 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 Group
    Following 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 Group
    Following 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

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax Medical CampusFalls ChurchVirginia22042
Bhruga Shah, MS, BSN
703-776-2828
Kedir Seid
17037762524
Shashank Sinha, MD MSc (PRINCIPAL_INVESTIGATOR)

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