Coronary Sinus Reducer for Symptomatic Coronary Microvascular Dysfunction

Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)

Recruiting N/A Interventional Study
Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Microvascular Angina
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
VahatiCor, Inc. · Industry
Who this trial is looking for

This trial is looking for adults with ongoing angina or similar symptoms caused by coronary microvascular dysfunction. Participants will receive a device designed to relieve their symptoms and will need to undergo several evaluations before being selected.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I have ongoing angina symptoms for at least 30 days.
  • I have been diagnosed with coronary microvascular dysfunction.
  • I have a left ventricular ejection fraction of 25% or more.
  • I have been on at least 2 anti-anginal medications.
  • I can sign informed consent.
  • I can attend follow-up evaluations.

You may not be able to join if

  • I have significant obstructive heart disease that can be treated surgically.
  • I have had a recent heart attack in the last 30 days.
  • I have untreated hyperthyroidism or severe anemia.
  • I have severe heart failure or have been hospitalized for heart failure recently.
  • I have severe rhythm disorders that need special treatment.
  • I have severe chronic obstructive pulmonary disease.
  • I am currently pregnant or planning to become pregnant soon.
  • I cannot tolerate certain medications for blood thinning or have conditions that limit my life expectancy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

VahatiCor's Coronary Sinus Reducer (A-FLUX) has been designed to improve angina or angina-like symptoms in patients with CMD. SERRA-I is an early feasibility study that evaluates the safety and clinical performance of the A-FLUX Reducer in this population.

Trial Locations
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Eligibility Criteria
Inclusion criteria 1. Older than 18 years of age. 2. Left ventricular ejection fraction (LVEF) is greater than or equal to 25% within the 12 months before the index procedure. Note: The LVEF must be reassessed after any intervening myocardial infarction. The most recent LVEF assessment is used as t…
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