Clin2
NCT04405583Possibly a fitRecruiting

Follow-up study for a heart device in heart failure patients

Heart Failure

Part of Heart & circulation clinical trials.

This study follows people with chronic heart failure to see how well an implanted device (called the Occlutech AFR) works and whether it is safe over time. It may help doctors better understand who benefits and how to manage treatment safely.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
150 people
Ages
18 years and older
Study type
Observational

Who can take part

  • You can sign written informed consent, and you are 18 or older
  • You have ongoing heart failure symptoms that are at least moderate (NYHA class 2 or higher)
  • You have higher pressure on the left side of the heart than the right side (a pressure difference of at least 5 mmHg on testing)
  • Your heart pumping strength is low enough to fit the study (LVEF at least 15%); if your pumping is fairly preserved, specific blood marker levels must be elevated
  • Your heart failure medicines have been stable for at least 1 month before joining
  • You do NOT have several serious conditions (like very advanced heart failure, major right-heart failure, certain valve disease, recent serious clots/bleeding, or major lung disease)

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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