Implantable monitor aims to keep shock survivors out of hospital
NCT ID NCT04419480
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests whether an implanted heart pressure monitor (CardioMEMS) can help prevent complications in 40 patients who survived cardiogenic shock. Participants will have the device implanted and receive regular pressure checks and medication adjustments. The goal is to see if this approach reduces deaths, hospital stays, and improves quality of life over 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CardioMEMS device (implanted heart pressure monitor)
- What this could lead to
- If successful, this could show that regular pressure monitoring helps prevent hospital readmissions and improves quality of life after cardiogenic shock.
- What could go wrong
- This is a small pilot study with only 40 participants, so results may not apply broadly. The device requires implantation, which carries procedural risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Inova Fairfax Medical Campus
RECRUITINGFalls Church, Virginia, 22042, United States
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