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RECRUITING
NCT06991322
NA

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

Sponsor: VahatiCor, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-06-18

Completion Date

2027-04

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DEVICE

A-FLUX Reducer System

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.

Locations (2)

University Medical Center Utrecht

Utrecht, Netherlands

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu

Warsaw, Poland