Angina PectorisSERRA-I USNCT07449325
Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
A study testing A-FLUX Reducer System in people with Angina Pectoris and Myocardial Ischemia, run by VahatiCor, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Myocardial Ischemia, Heart Diseases
- What is being tested?
- A-FLUX Reducer System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Willing and able to sign informed consent.
- 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).
- Mean right atrial pressure ≤15 mmHg.
- The CS anatomy is suitable for implantation at the Investigator's discretion
Who cannot join
- 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.
- 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).
- 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.
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- 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.
- 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.
- Comorbidities limiting life expectancy to less than one year.
- Currently hospitalized for definite or suspected COVID-19.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Yale University
New Haven, Connecticut, 06511
About this study
Official title: 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.
- Conditions
- Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Microvascular Angina
- Being tested
- A-FLUX Reducer System
- Medical subject headings
- Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-FLUX Reducer SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device: A-FLUX Reducer System | Other | Treatment Receives: Device: A-FLUX Reducer System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start7 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study suspended to implement a protocol change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VahatiCor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449325
- Sponsor's protocol ID
- VHC-00004
- Acronym
- SERRA-I US
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
- ClinicalTrials.gov ID
- NCT07449325
- Acronym / sponsor ID
- SERRA-I US / VHC-00004
- Conditions
- Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Microvascular Angina
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended to implement a protocol change
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VahatiCor, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: A-FLUX Reducer System | Other | Device: A-FLUX Reducer SystemTreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
- 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).
- NYHA class IV or decompensated HF or hospitalization due to HF during the 90 days before the index procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-FLUX Reducer SystemThe 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 | Device: A-FLUX Reducer System |
Primary outcome
Procedural Success
Time frame: Throughout the study, up to 12 months post-procedure
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
Safety: Rate of device- and procedure- related SAEs
Time frame: Through 30 days post-procedure
Rate of device- and procedure-related SAEs. SAEs include cardiac death, CS perforation, device embolization, and cardiac tamponade
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-FLUX Reducer System in people with Angina Pectoris and Myocardial Ischemia, run by VahatiCor, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: Throughout the study, up to 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.