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

NCT06991322 | Recruiting FDA Device

• 1 other identifier: VHC-00002
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• 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

Coronary Microvascular Dysfunction; Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (2)

• Procedural Success

  Successful delivery and deployment of VahatiCor A-FLUX Reducer System

  Throughout the study, up to 12 months post-procedure

• Safety: Rate of device- and procedure- related SAEs

  Rate of device- and procedure-related SAEs.

  30-days post-procedure

Study Arms (1)

Treatment

OTHER

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.

Treatment

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.
• 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.
• CFR\<2.5 measured with continuous thermodilution within 30 days of index procedure.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• VahatiCor, Inc.: lead

Study Sites (2)

University Medical Center Utrecht

Utrecht, 3584, Netherlands

RECRUITING

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Madison Kenley, BS

CONTACT

+1(801)552-8383; mkenley@vahaticor.com

Janie Mandrusov, PhD

CONTACT

clinicalaffairs@vahaticor.com

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: May 19, 2025
• First Posted: May 27, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

NL (1); PL (1)