Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06991322

Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)

Led by VahatiCor, Inc. · Updated on 2025-12-23

30

Participants Needed

2

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 18 years of age.
  • Left ventricular ejection fraction (LVEF) is greater than or equal to 25% within the 12 months before the index procedure.
  • Persistent symptomatic coronary microvascular dysfunction (angina pectoris or equivalent symptoms) for 30 days or more, classified as CCS Grade II-IV angina or NYHA Class 2 or 3 equivalent non-anginal functional impairment, despite optimal medical therapy.
  • Coronary flow reserve less than 2.5 measured with continuous thermodilution within 30 days of the procedure.
  • Sustained angina or equivalent symptoms reported for at least 2 weeks leading up to the procedure, as recorded via the ORBITA-app.
  • Willing and able to sign informed consent.
  • Willing to comply with specified follow-up evaluations.
  • Mean right atrial pressure less than or equal to 15 mmHg.
  • Coronary sinus anatomy suitable for implantation as determined by the Investigator.
Not Eligible

You will not qualify if you...

  • Significant obstructive epicardial disease (greater than 50% diameter stenosis) treatable with PCI or CABG.
  • Acute coronary syndrome (NSTEMI or STEMI) with positive troponin or CKMB within 30 days before the procedure.
  • Extra-coronary causes of angina such as untreated hyperthyroidism, severe anemia (Hgb less than 9 g/dL), uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg despite medications), atrial fibrillation with rapid ventricular response (>100 bpm despite medications), severe aortic stenosis, decompensated heart failure, or hypertrophic cardiomyopathy with left ventricular outflow tract obstruction.
  • NYHA class IV heart failure, decompensated heart failure, or hospitalization due to heart failure within 90 days before the procedure.
  • Life-threatening or rhythm disorders requiring cardiac resynchronization therapy or coronary sinus lead placement.
  • Severe COPD indicated by FEV1 less than 1.0L, need for home oxygen, or regular oral steroids.
  • Severe valvular heart disease.
  • Moderate or severe right ventricular dysfunction by echocardiography.
  • Presence of a pacemaker lead in the coronary sinus.
  • Recent pacemaker or defibrillator lead implantation in the right atrium within 90 days.
  • Chronic severe renal failure (eGFR less than 30 mL/min/1.73m2) or on chronic dialysis.
  • Known allergy to titanium, nickel, platinum, tungsten, or inability to tolerate contrast medium.
  • Any condition interfering with trial compliance, including active substance use or cognitive decline.
  • Enrollment in another investigational device or drug trial that may interfere with this study.
  • Pregnancy or planning pregnancy within 12 months (females must have a negative pregnancy test within 7 days of procedure).
  • Vulnerable populations unable to give informed consent.
  • Inability to tolerate dual antiplatelet therapy or P2Y12 inhibitors for at least 6 months as required.
  • Comorbidities limiting life expectancy to less than one year.
  • Currently hospitalized for definite or suspected COVID-19.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University Medical Center Utrecht

Utrecht, Netherlands, 3584

Actively Recruiting

2

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu

Warsaw, Poland

Actively Recruiting

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Research Team

M

Madison Kenley, BS

CONTACT

J

Janie Mandrusov, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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