Recruiting

Hemodynamic Monitoring

Sponsor:

Inova Health Care Services

Code:

NCT04419480

Conditions

Cardiogenic Shock

Heart Failure

Ambulatory Hemodynamic Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Study Details

Brief summary:

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock

Conditions

Cardiogenic Shock

Heart Failure

Ambulatory Hemodynamic Monitoring

Study ID

NCT04419480

Start date

Dec 31, 2020

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
2. Age ≥ 18 years
3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure < 90 mmHg for > 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output < 30 mL/h, or serum lactate > 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.
5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).

Exclusion Criteria:

1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
3. If of childbearing potential with a positive pregnancy test.
4. Transition to hospice care.
5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
6. Presence of an active, uncontrolled infection.
7. Any condition other than heart failure that could limit survival to less than 6 months
8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.
9. No access to internet or phone.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

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.

Primary outcome measure

  • Hierarchical primary endpoint [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Inova Fairfax Medical Campus

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Shashank Sinha, MD MSc

More Information

Sponsor

Inova Health Care Services

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-03-16.