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New treatment option for Coronary Microvascular Dysfunction
Official title Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)
ClinicalTrials.gov ID: NCT06991322
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join if
- Significant obstructive epicardial disease (greater than 50% diameter stenosis) that can be treated with PCI or CABG as determined by Investigator...
- Recent (less than 30 days before index procedure) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) with evidence of ischemia.
- Extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, anemia (Hgb less than 9 g/dL), uncontrolled hypertension (systolic...
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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...
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Netherlands
- Warsaw, Poland
- Barcelona, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Netherlands; Warsaw, Poland; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.