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Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): the CORCINCH-HF Study

Studying a new heart device for heart failure patients.

Recruiting
18 years and older
All
Phase N/A

The CORCINCH-HF Study is testing a device called the AccuCinch Ventricular Restoration System to help people with heart failure, a condition where the heart doesn't pump blood well. The study will compare two groups: one will receive the AccuCinch device plus regular heart medicine, and the other will only take the regular heart medicine. Heart failure with reduced ejection fraction (HFrEF) means the heart's left ventricle (main pumping chamber) can't pump out the normal amount of blood. The ejection fraction (EF) is a measure of how well the heart pumps, and should be between 20% and 40% for participants.

Key Points:

  • The study involves two groups, each with around 200 people. One group will get the device and medicine; the other, just medicine.
  • Participants must be 18 or older and able to walk a certain distance in 6 minutes.
  • Eligible participants must be on stable heart medication for at least 30 days before joining.

Participants should be ready for tests and follow-up visits. They should not have had recent heart surgery or conditions like severe valve problems or certain heart diseases. Pregnant women or those without birth control should not participate.

Study details
    Heart Failure with Reduced Ejection Fraction (HFrEF)
    Dilated Cardiomyopathy

NCT04331769

Ancora Heart, Inc.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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