J-Valve Transfemoral Pivotal Study

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Study ID
NCT06455787
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Valve Disease Mixed
  • Aortic Valve Regurgitation

Eligibility Criteria

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

Interventions

  • J-Valve Transfemoral (TF) System — DEVICE
    Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.

Study Details

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Key Dates

Start date
Oct 17, 2024
Status verified
Aug 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2032

Study Design

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

Arms

  • Experimental: J-Valve Transfemoral (TF) System

Primary Outcome Measure

All-cause mortality at 1 year [ Time Frame: 1-year post-procedure ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
HonorHealth Research & Innovation InstituteScottsdaleArizona85258
Andrew Cluckey, MD (PRINCIPAL_INVESTIGATOR)
Scripps Memorial Hospital La JollaLa JollaCalifornia92037
Curtiss Stinis, MD (PRINCIPAL_INVESTIGATOR)
Cedars SinaiLos AngelesCalifornia90048
Raj Makkar, MD (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CenterPalo AltoCalifornia94394
John MacArthur, MD (PRINCIPAL_INVESTIGATOR)
Bay Area Structural Heart at Sutter HealthSan FranciscoCalifornia94109
David Daniels, MD (PRINCIPAL_INVESTIGATOR)
University of California San FranciscoSan FranciscoCalifornia94143
Sammy Elmariah, MD (PRINCIPAL_INVESTIGATOR)
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColorado80538
Mark Tuttle, MD (PRINCIPAL_INVESTIGATOR)
Washington Hospital Center DCWashington D.C.District of Columbia20010
Ron Waksman, MD (PRINCIPAL_INVESTIGATOR)
NCH Rooney Heart InstituteNaplesFlorida34102
Robert Cubeddu, MD (PRINCIPAL_INVESTIGATOR)
Emory University AtlantaAtlantaGeorgia30308
Vasilis Babaliaros, MD (PRINCIPAL_INVESTIGATOR)
PiedmontAtlantaGeorgia30309
Vinod Thourani, MD (PRINCIPAL_INVESTIGATOR)
Northwestern University ChicagoChicagoIllinois60611
Anita Asgar, MD (PRINCIPAL_INVESTIGATOR)
Glenbrook - Endeavor HealthGlenviewIllinois60026
Mark Ricciardi, MD (PRINCIPAL_INVESTIGATOR)
Ascension Via ChristiWichitaKansas67214
Bassem Chehab, MD (PRINCIPAL_INVESTIGATOR)
Brett Grizzell, MD (SUB_INVESTIGATOR)
Cardiovascular Institute of the SouthHoumaLouisiana70360
Peter Fail, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Pinak Shah, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital BostonBostonMassachusetts02114
Ignacio Inglessis-Azuaje, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Hospital DetroitDetroitMichigan48202
Pedro Villablanca, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Konstantinos Voudris, MD (PRINCIPAL_INVESTIGATOR)
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303
Brian Stegman, MD (PRINCIPAL_INVESTIGATOR)
Washington University - Barnes-Jewish Hospital St. LouisSt LouisMissouri63110
Alan Zajarias, MD (PRINCIPAL_INVESTIGATOR)
University at Buffalo - Kaleida HealthBuffaloNew York14203
Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical Center/New York-Presbyterian HospitalNew YorkNew York10032
Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR)
St. Francis HospitalRoslynNew York11576
George Petrossian, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Mohamed A Latib, MD (PRINCIPAL_INVESTIGATOR)
Carolinas Health System (Atrium)CharlotteNorth Carolina28204
Jonathan Schwartz, MD (PRINCIPAL_INVESTIGATOR)
The Christ Hospital and The Carl & Edyth Lindner Center for Research and EducationCincinnatiOhio45219
Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Harsh Golwala, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. Thomas West HospitalNashvilleTennessee37205
Andrew Morse, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Brian Lindman, MD (PRINCIPAL_INVESTIGATOR)
HCA Houston Healthcare Medical CenterHoustonTexas77004
Pravac Loyalka, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Sachin Goel, MD (PRINCIPAL_INVESTIGATOR)
The Heart Hospital - Baylor PlanoPlanoTexas75093
Molly Szerlip, MD (PRINCIPAL_INVESTIGATOR)
Swedish Heart & Vascular ResearchSeattleWashington98122
Sameer A Gafoor, MD (PRINCIPAL_INVESTIGATOR)

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HonorHealth Research & Innovation Institute· Scottsdale, AZScripps Memorial Hospital La Jolla· La Jolla, CACedars Sinai· Los Angeles, CAStanford University Medical Center· Palo Alto, CABay Area Structural Heart at Sutter Health· San Francisco, CAUniversity of California San Francisco· San Francisco, CA

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