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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
VahatiCor, Inc.
Study ID
NCT07449325
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Device: A-FLUX Reducer System
    Treatment

Primary Outcome Measure

Procedural Success [ Time Frame: Throughout the study, up to 12 months post-procedure ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Rayyan Qureshi
[email protected]
203-785-4129
Samit Shah, MD, PhD (PRINCIPAL_INVESTIGATOR)
The Lindner Research Center at The Christ HospitalCincinnatiOhio45219
Rebecca Harper, DNP, RN, CNP
[email protected]
513-585-1777
Odayme Quesada, MD (PRINCIPAL_INVESTIGATOR)
Tim Henry, MD (SUB_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTThe Lindner Research Center at The Christ Hospital· Cincinnati, OH

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