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TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease | Clinical Trials | Clareo Health

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TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study

NCT05536310•JenaValve Technology, Inc.

View on ClinicalTrials.gov

Summary

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

Detailed Description

Aortic stenosis (AS) is a narrowing of the aortic valve opening causing restricted blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. Aortic regurgitation (AR) is a condition where the aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AS and AR may include fatigue and shortness of breath. Aortic valve disease can affect both elderly and younger populations. TAVIS Registry will collect data from patients suffering from either AS or AR using a minimally invasive transcatheter aortic valve implantation procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care
•2. Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for "bail out"/to address unfavorable circumstances if necessary
•3. Patients 18 years of age or older
•4. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study
•5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria

•1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication
•2. Patients who have active bacterial endocarditis or other active infections
•3. Pediatric (\<18 years) and/or pregnant/nursing patients
•4. Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
•5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
•6. Echocardiographic evidence of current left heart thrombus
•7. Hypertrophic cardiomyopathy with or without obstruction.
•8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \<7mm.

Locations (3)

Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen

Bad Oeynhausen, Germany

University Hospital of Cologne Heart Center

Cologne, Germany

University Hospital Mainz

Mainz, Germany

Key Dates

Start Date

March 1, 2023

Primary Completion Date

October 1, 2023

Completion Date

October 1, 2027

Last Updated

January 11, 2023

Enrollment

600

ESTIMATED participants

Conditions

Aortic Valve StenosisAortic Valve RegurgitationAortic Valve Stenosis With InsufficiencyConstriction, PathologicAortic Valve DiseaseHeart Valve DiseasesCardiovascular Diseases in Old AgeVentricular Outflow ObstructionAortic Stenosis, Severe

Interventions

Transcatheter Aortic Valve Implantation (TAVI)

DEVICE

Contacts

Vinny Podichetty, Vice President: Clinical & Med Affairs

CONTACT

949-767-2110 podichetty@jenavalve.com

Post-Dilatation Effect on TAVI Prostheses Expansion

NCT07477002

Aortic Valve Stenosis

View study

RECRUITINGNA

J-Valve Transfemoral Pivotal Study

NCT06455787

Aortic Valve RegurgitationAortic Valve Disease Mixed

View study

RECRUITINGPHASE4

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Inclusion Criteria

Exclusion Criteria

Post-Dilatation Effect on TAVI Prostheses Expansion

J-Valve Transfemoral Pivotal Study

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

Effect of Fetal Aortic Valvuloplasty on Outcomes

Translational-Omics in Aortic Stenosis (TOmAS) Biobank

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR