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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Microvascular Angina
• Intervention / Treatment: Device: A-FLUX Reducer System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale University
      • Contact: Rayyan Qureshi; Phone Number: 203-785-4129; Email: rayyan.qureshi@yale.edu
      • Principal Investigator: Samit Shah, MD, PhD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Lindner Research Center at The Christ Hospital
      • Principal Investigator: Odayme Quesada, MD
      • Sub-Investigator: Tim Henry, MD
      • Contact: Rebecca Harper, DNP, RN, CNP; Phone Number: 513-585-1777; Email: Rebeccam.harper@thechristhospital.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 the qualifying test for subjects with multiple assessments
3. Greater than or equal to 30 days of persistent symptomatic coronary microvascular dysfunction (angina pectoris, or equivalent symptoms) (classified as CCS Grade II - IV angina, or NYHA Class 2 or 3 equivalent non-anginal functional impairment) despite optimal medical therapy, as determined by Investigator and confirmed by the Central Screening Committee. Note: Optimal medical management is defined as at least 2 anti-anginal medications or maximally tolerated medical therapy if less than 2 anti-anginal medications.

4. CFR<2.5 measured with continuous thermodilution within 30 days of index procedure. Note: CFR assessment may be completed during index procedure by Sponsor approved Investigators. RCA measurements are not permitted for this study.

   Note: CFR should be measured in LAD or LCX if LAD is not feasible. RCA measurements are not permitted for this study

5. Sustained angina (or equivalent symptoms) reported for at least 2 weeks leading up to the index procedure, as reported via the ORBITA-app.
6. Willing and able to sign informed consent.

7. Willing to comply with the specified follow-up evaluations.

   Procedural Angiographic/Hemodynamic Inclusion Criteria:

   The following will be assessed during the index procedure to confirm eligibility before an attempt at implantation. Note: CFR assessment may be completed during index procedure by Sponsor approved Investigators if not yet obtained in the prior 30 days (see inclusion criteria 4).

8. Mean right atrial pressure ≤15 mmHg.
9. The CS anatomy is suitable for implantation at the Investigator's discretion

Exclusion Criteria

1. Significant obstructive epicardial disease (greater than 50% diameter stenosis) that can be treated with PCI or CABG as determined by Investigator and confirmed by the Central Screening Committee.

2. Recent (less than 30 days before index procedure) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) with evidence of ischemia.

   Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be considered eligible.

3. Extra-coronary contributory causes of angina- e.g., untreated hyperthyroidism, anemia (Hgb less than 9 g/dL), uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg despite medications), atrial fibrillation with a rapid ventricular response (consistently greater than 100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, decompensated heart failure, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion).
4. NYHA class IV or decompensated HF or hospitalization due to HF during the 90 days before the index procedure.
5. Life-threatening rhythm disorders or any rhythm disorders that would require cardiac resynchronization therapy or lead placement in the coronary sinus.
6. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) of less than 1.0L or need for home daytime oxygen or regular oral steroids.
7. Severe valvular heart disease (any valve).
8. Moderate (TAPSE<12) or severe RV dysfunction (TAPSE<8) by echocardiography.
9. A pacemaker electrode/lead is present in the coronary sinus.
10. Recent implantation of a new pacemaker or defibrillator leads with any electrode in the right atrium within 90 days of the index procedure.
11. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 or equivalent) or subjects on chronic dialysis.
12. Known allergy to titanium, nickel, platinum, tungsten, or known inability to tolerate contrast medium
13. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or illicit substance use, cognitive decline).
14. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or might clinically interfere with the current trial endpoints or procedures.
15. Pregnant or planning pregnancy within the next 12 months (females of reproductive potential must have a negative pregnancy test within 7 days of the procedure).
16. Part of a vulnerable population who, in the investigator's judgment, cannot give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances, or lack of autonomy.
17. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant.
18. Comorbidities limiting life expectancy to less than one year.
19. Currently hospitalized for definite or suspected COVID-19.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Device: A-FLUX Reducer System; Treatment	Device: A-FLUX Reducer System; The VahatiCor A-FLUX Reducer System is an implantable, self-expanding dense-cell nitinol coronary sinus flow restrictor device pre-loaded into the A-FLUX Delivery Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	Successful delivery and deployment of VahatiCor A-FLUX Reducer System to the intended site and Delivery Catheter retrieval without device-and procedure-related SAEs. SAEs include cardiac death, CS perforation, device embolization, and occurrence of pericardial effusion	Throughout the study, up to 12 months post-procedure
Safety: Rate of device- and procedure- related SAEs	Rate of device- and procedure-related SAEs. SAEs include cardiac death, CS perforation, device embolization, and cardiac tamponade	Through 30 days post-procedure

Collaborators and Investigators

• Sponsor: VahatiCor, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Myocardial Ischemia; Angina Pectoris; Microvascular Angina
• Other Study ID Numbers: VHC-00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No