RecruitingInterventional · Not applicableNCT04097145 ↗A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
Active, not recruitingInterventional · Not applicableNCT04153292 ↗SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal AccessShmuel ChenPIInterventionDevice: SAPIEN M3 valve and dockDatesNov 2020 – Oct 2027 (est.)SponsorEdwards Lifesciences Corp.Mitral RegurgitationMitral Valve Insufficiency
Active, not recruitingInterventional · Not applicableNCT04482062 ↗Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel DeviceShmuel ChenPIInterventionDevice: Edwards EVOQUE System · Drug: Optimal Medical TherapyDatesApr 2021 – Dec 2025SponsorEdwards Lifesciences Corp.Tricuspid Valve RegurgitationTricuspid Valve InsufficiencyTricuspid Valve Disease+3 more
RecruitingInterventional · Not applicableNCT05172973 ↗Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic ValvesShmuel ChenPIInterventionDevice: SAPIEN X4/X4S THVDatesNov 2023 – Mar 2029 (est.)SponsorEdwards Lifesciences Corp.Aortic Valve InsufficiencyAortic Valve Stenosis
RecruitingInterventional · Not applicableNCT06212193 ↗Early Feasibility Study (EFS) to Assess the Safety and Performance of the Innoventric Trillium™ Stent Graft in the Treatment of Severe or Greater Tricuspid Regurgitation (TR)Shmuel ChenPIInterventionDevice: Trillium™DatesAug 2024 – Dec 2026 (est.)SponsorInnoventric LTDTricuspid RegurgitationTricuspid Regurgitation Functional
CompletedInterventional · Not applicableNCT04618718 ↗Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C TrialShmuel ChenPIInterventionDevice: cerebral embolic protection during TAVRDatesJul 2020 – Nov 2022· Results postedSponsorProtembis GmbHValvular Heart Disease