Heart Disease Trial, Recruiting NCT04419480 Sponsor: Inova Health Care Services Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT04419480
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The patient (or their legal representative) has signed a consent form, and the investigator considers the patient able to participate and complete study questionnaires.
  • Adults aged 18 years or older.
  • People diagnosed with a moderate-to-severe level of heart failure (called NYHA Class III), meaning they experience breathlessness with mild physical activity, regardless of how well the heart pumps.
  • People who experienced a serious episode of heart failure called cardiogenic shock during a current hospital stay — where blood pressure dropped dangerously low or required special medications to keep it stable, along with signs that organs were affected (such as fluid in the lungs, confusion, very low urine output, or abnormal blood test results) — and who survived to be discharged from hospital.
  • People who have access to the internet and a phone, so that the implanted device can communicate with the research team.

Who may not be able to join:

  • People for whom the procedure would carry an unusually high risk, based on the investigator's assessment.
  • People who are already using a long-term mechanical heart support device (such as a permanent heart pump), or who received a heart transplant during the same hospital stay for cardiogenic shock.
  • People who are pregnant (confirmed by a positive pregnancy test), if there is a possibility of pregnancy.
  • People who are transitioning to hospice or end-of-life care.
  • People who are unable to tolerate or are unlikely to be able to take anti-clotting medication consistently for one year after the device is implanted.
  • People who have an active infection that is not under control.
  • People who have another medical condition (separate from heart failure) that may limit survival to less than 6 months.
  • People being discharged somewhere other than an acute rehabilitation facility or returning home.
  • People without access to the internet or a phone.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Shashank Sinha, MD MSc, Inova Fairfax Medical Campus

Phone: 7037764001

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Inova Health Care Services
Registry
ClinicalTrials.gov
Start date
31 December 2020
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Hierarchical primary endpoint

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov