An interventional study of Remote cardiovascular monitoring at home in Myocardial Infarction, Myocarditis Acute and Pericarditis, sponsored by Tel-Aviv Sourasky Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Health services research
Hospital-at-Home (H@H) programs provide hospital-level acute care in the patient's home and may reduce healthcare utilization while improving patient experience. Although H@H models have been evaluated in several acute medical populations, evidence regarding their safety and efficacy in a broad population of patients with acute cardiovascular conditions remains limited.
HeaRt@Home is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of H@H compared with standard in-hospital care in clinically stable cardiac patients admitted to Tel Aviv Sourasky Medical Center. The study will enroll 150 adults hospitalized for selected cardiovascular conditions, including acute myocardial infarction following uncomplicated percutaneous coronary intervention, pericarditis or myocarditis, pulmonary embolism, post transcatheter valvular intervention, acute or worsening heart failure, or following Pacemaker or Implantable Cardioverter-Defibrillator Implantation.
Eligible patients will be assessed within the first 12-24 hours following clinical intervention and randomized to either continued standard hospitalization or H@H care. Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required.
The study will assess safety outcomes including all-cause mortality, hospital-acquired infections, hemodynamic deterioration, acute kidney injury, venous thromboembolism, medication errors, 30-day readmission, and 30-day mortality. Patient experience will be evaluated using the 15-item Picker Patient Experience Questionnaire. Secondary outcomes will include length of stay, healthcare resource utilization, mobility and physical activity, sleep, arrhythmias, need for escalation to hospital care, and psychological outcomes.
The study aims to determine whether a structured, technology-supported H@H model can provide safe and effective hospital-level care for appropriately selected cardiovascular patients while potentially improving patient experience and optimizing healthcare resource utilization.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Disease-Specific Inclusion Criteria
In addition to the general inclusion criteria, patients must meet the relevant disease-specific criteria:
Acute Myocardial Infarction
Acute myocardial infarction with or without ST-segment elevation (STEMI or NSTEMI), treated with primary percutaneous coronary intervention (PCI). The intervention must have been performed in a coronary artery other than the proximal left anterior descending (LAD) artery or left main coronary artery, with TIMI grade III flow at the end of the procedure, no additional critical coronary artery stenoses, an uncomplicated PCI without periprocedural complications, and preserved left ventricular systolic function ( >45%).
Pericarditis/Myocarditis
Initial diagnosis of pericarditis or myocarditis, with no more than a mild pericardial effusion and preserved left ventricular systolic function (LVEF ≥50%).
Pulmonary Embolism
Low-intermediate-risk pulmonary embolism following echocardiographic and CT angiographic (CTA) assessment and treatment with oral or subcutaneous anticoagulation; or intermediate-high-risk pulmonary embolism following successful mechanical thrombectomy, with subsequent improvement in hemodynamic and echocardiographic parameters.
Following Transcatheter Valve Replacement or Repair
Patients following uncomplicated transcatheter aortic valve replacement (TAVR), or transcatheter edge-to-edge repair (TEER) of the mitral or tricuspid valve, with no clear indication for pacemaker implantation.
Heart Failure
Newly diagnosed (de novo) heart failure or worsening of pre-existing heart failure, regardless of left ventricular ejection fraction (LVEF), with symptomatic functional class II-IV heart failure requiring hospitalization.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy,and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required.
Other: Remote cardiovascular monitoring at home
Patients assigned to this arm will be monitored with the same continuous remote monitoring device and treated with the standard routine hospital care
Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required.
Composite Primary Safety Outcomes number of Events
The total number of events - Each of the following events will be contented is 1 unit: including all-cause mortality during hospitalization; Hospital-acquired infections; Hemodynamic deterioration requiring inotropic treatment and/or mechanical ventilation; Acute kidney injury according to KDIGO criteria; Deep vein thrombosis and/or pulmonary embolism; Medication administration errors; Hospital readmission within 30 days; and All-cause mortality within 30 days.
Time frame: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge
Patient Experience Questionnaire
The total score of the 15-item Picker Patient Experience Questionnaire.
Time frame: Questionnaire filled at the day of discharge from admission, an average of 3-5 days, and refers to the hospitalization duration.
Composite Secondary Endpoints number of Events
Duration of hospitalization; Number of diagnostic tests performed during hospitalization, including laboratory tests, imaging examinations, Holter monitoring, and specialist consultations; Number and duration of intravenous treatments; Number of hours of oxygen treatment per day; Episodes of peripheral intravenous-line phlebitis; Episodes of venous thromboembolism; Episodes of acute kidney injury; Requirement for urinary catheterization; Medication administration errors; Falls; Mobility and number of active hours per day measured by continuous monitoring; Daily step count; Hours of sleep per day; Cardiac arrhythmias, including atrial fibrillation, atrial flutter, ventricular tachycardia, and second-degree or higher atrioventricular conduction abnormalities; Requirement for transfer from H@H to conventional hospital care; Number of daily nursing visits; Number of daily cardiologist assessments; Cardiac and all-cause hospital readmission within 30 days; All-cause mortality at 30 days;
Time frame: 1. Through hospitalization completion, an expected average of 3-5 days 2. Re-hospitalization and all-cause mortality at 30 days following discharge
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Nov 2027, 17 months after the start.
Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 17 months is below that.
Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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