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Clinical trial

The AMEND TS Early Feasibility Study is a Prospective, Single-arm, Multi-center Study to Evaluate the Safety and Function of the AMEND(TM) Trans-Septal System for MR Reduction; Up to 15 Subjects Will be Enrolled in up to 7 Investigational Centers in the U.S. and Canada With a 30d Safety Endpoint

NCT06951672 is registered in ClinicalTrials.gov with Valcare Medical Ltd. as lead sponsor.

NCT NCT06951672
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Registry record

As filed in ClinicalTrials.gov.

Title
The AMEND TS Early Feasibility Study is a Prospective, Single-arm, Multi-center Study to Evaluate the Safety and Function of the AMEND(TM) Trans-Septal System for MR Reduction; Up to 15 Subjects Will be Enrolled in up to 7 Investigational Centers in the U.S. and Canada With a 30d Safety Endpoint
Lead sponsor
Valcare Medical Ltd.
Phase
Not applicable
Overall status
Recruiting
Start date
September 11, 2025
Completion date
April 30, 2027
Enrollment
15 (estimated)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.

symptomatic functional mr 3 or greater