The JenaValve ALIGN-AR LVAD Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
JenaValve Technology, Inc.
Study ID
NCT06594705
Status
Recruiting
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Conditions

  • Aortic Insufficiency
  • Aortic Regurgitation
  • Aortic Valve Disease
  • Aortic Valve Insufficiency
  • Left Ventricular Dysfunction

Eligibility Criteria

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

Interventions

  • JenaValve Trilogy Heart Valve System — DEVICE
    TAVR with JenaValve Trilogy Heart Valve System

Study Details

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

Key Dates

Start date
Dec 9, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: TAVR in LVAD Patients
    Transcatheter Aortic Valve Replacement (TAVR) TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR)

Primary Outcome Measure

Device Success [ Time Frame: 30 days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Sutter HealthSan FranciscoCalifornia94109-
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010-
Emory UniversityAtlantaGeorgia30308-
PiedmontAtlantaGeorgia30309-
Advocate Christ Medical CenterOak LawnIllinois60453-
University of MichiganAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
Washington University, St. LouisSt LouisMissouri63130-
Columbia University Medical Center/New York-Presbyterian HospitalNew YorkNew York10032-
Houston Methodist Research CenterHoustonTexas77030-
BaylorPlanoTexas75024-
IntermountainMurrayUtah84107-
Sentara Norfolk General HospitalNorfolkVirginia23507-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CASutter Health· San Francisco, CAMedstar Washington Hospital Center· Washington D.C., DCEmory University· Atlanta, GAPiedmont· Atlanta, GAAdvocate Christ Medical Center· Oak Lawn, IL

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