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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madison Kenley, BS | Contact | +1(801)552-8383 | mkenley@vahaticor.com | |
| Janie Mandrusov, PhD | Contact | clinicalaffairs@vahaticor.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Recruiting | Utrecht | 3584 | Netherlands |
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| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu | Recruiting | Warsaw | Poland |
|
| Hospital ClĂnic Barcelona | Recruiting | Barcelona | Spain |
|
| ID | Term |
|---|---|
| D017566 | Microvascular Angina |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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