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

NCT07449325 | Recruiting DMC FDA Device

• 1 other identifier: VHC-00004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Microvascular Angina

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device: A-FLUX Reducer System

OTHER

Treatment

Device: A-FLUX Reducer System

Interventions

A-FLUX Reducer System DEVICE

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.

Device: A-FLUX Reducer System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. 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
• 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.
• 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
• Sustained angina (or equivalent symptoms) reported for at least 2 weeks leading up to the index procedure, as reported via the ORBITA-app.
• Willing and able to sign informed consent.
• Willing to comply with the specified follow-up evaluations.
• Mean right atrial pressure ≤15 mmHg.
• The CS anatomy is suitable for implantation at the Investigator's discretion

You may not qualify if:

• 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.
• 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.
• NYHA class IV or decompensated HF or hospitalization due to HF during the 90 days before the index procedure.
• Life-threatening rhythm disorders or any rhythm disorders that would require cardiac resynchronization therapy or lead placement in the coronary sinus.
• 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.
• Severe valvular heart disease (any valve).
• Moderate (TAPSE\<12) or severe RV dysfunction (TAPSE\<8) by echocardiography.
• A pacemaker electrode/lead is present in the coronary sinus.
• Recent implantation of a new pacemaker or defibrillator leads with any electrode in the right atrium within 90 days of the index procedure.
• Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 or equivalent) or subjects on chronic dialysis.
• Known allergy to titanium, nickel, platinum, tungsten, or known inability to tolerate contrast medium
• 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).
• 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.
• 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).

Sponsors & Collaborators

• VahatiCor, Inc.: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Microvascular Angina

Condition Hierarchy (Ancestors)

Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)