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CardioMEMS HF System Coverage With Evidence Development Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether using the CardioMEMS HF System to guide heart failure care improves health over time in everyday care. The system measures pressure in an artery that carries blood to the lungs. The study is for adults with a history of sudden worsening of heart failure or fluid buildup linked to heart failure.

The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the treatment group only: Have a CardioMEMS pressure sensor implanted in your body.
  • Be at least 18 years old when the sensor is implanted.
  • Have a history of sudden worsening of heart failure or related fluid buildup, shown by a hospital stay for heart failure or high BNP/NT-proBNP levels. These blood markers can show strain on the heart.

Who can't join

  • Have had a heart transplant or a long-term device that helps pump blood.
  • Are hospitalized with cardiogenic shock, when the heart cannot pump enough blood, or sepsis, a serious body-wide response to infection.
  • For the comparison group only: Have previously had a pressure sensor implanted in the artery that carries blood to the lungs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only) 2. Subject \>=18 years of age at time of implant 3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP Exclusion Criteria: 1. Subject has history of heart transplant or durable mechanical circulatory device 2. Subject hospitalized with cardiogenic shock or sepsis 3. Subject received prior PA pressure sensor implant (control arm only)

Study sites (1)

CA