Cephea Transseptal Mitral Valve System FIH | NCT03988946 | Trialant

Cephea Transseptal Mitral Valve System FIH | NCT03988946 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transcatheter Mitral Valve Replacement	Experimental	Replacement valve delivered through a transfemoral access and transseptal approach	Device: Transcatheter Mitral Valve Replacement via Transseptal Access

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Mitral Valve Replacement via Transseptal Access	Device	The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as measured by freedom from major adverse events	Freedom from major adverse events, including: All-cause mortality Disabling stroke Myocardial infarction Renal failure requiring dialysis Life-threatening bleeding Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.	30 days
Performance	Reduction in mitral regurgitation to ≤1+	30 days

Contacts/Locations Module

Condition Browse Module