TAVIS Registry - Trilogy Heart Valve System for Managemen... | NCT05536310

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

NCT05536310

Sponsor

JenaValve Technology, Inc.

Status

Not yet recruiting

Last Update Posted

Jan 11, 2023Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Aortic Valve Stenosis
Aortic Valve Regurgitation
Aortic Valve Stenosis With Insufficiency
Constriction, Pathologic
Aortic Valve Disease
Heart Valve Diseases
Cardiovascular Diseases in Old Age
Ventricular Outflow Obstruction
Aortic Stenosis, Severe

Interventions

Transcatheter Aortic Valve Implantation (TAVI)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Oct 2023Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Sep 7, 2022

First Submission Date that Met QC Criteria

Sep 7, 2022

First Posted Date

Sep 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 11, 2023Actual

Description Module

Brief 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trilogy TAVI		Patients receiving JenaValve Trilogy Heart Valve System for management of symptomatic, severe aortic stenosis (AS)/ aortic regurgitation (AR) who are at high risk for surgical aortic valve replacement (SAVR)	Device: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Aortic Valve Implantation (TAVI)	Device	TAVI with the JenaValve Trilogy Heart Valve System	Trilogy TAVI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	Mortality from any cause in patients receiving TAVI for AR or AS	30-days post-index procedure

Secondary Outcomes

Measure	Description	Time Frame
Death	Reported death in patients participating in TAVIS Registry	1 year
Stroke	Reported stroke in patients participating in TAVIS Registry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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
Patients 18 years of age or older
Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study
The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

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
Patients who have active bacterial endocarditis or other active infections
Pediatric (<18 years) and/or pregnant/nursing patients
Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
Echocardiographic evidence of current left heart thrombus
Hypertrophic cardiomyopathy with or without obstruction.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with symptomatic severe aortic regurgitation or symptomatic severe aortic stenosis undergoing treatment with JenaValve Trilogy Heart Valve System

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vinny Podichetty, Vice President: Clinical & Med Affairs	Contact	949-767-2110	1050	podichetty@jenavalve.com

Overall Officials

Name	Affiliation	Role
Stephan Baldus, MD	University Hospital of Cologne Heart Center	Principal Investigator
Hendrik Treede, MD	Johannes Gutenberg University Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen		Bad Oeynhausen		32545	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28314623	Background	Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
28298458

ID	Term
D001024	Aortic Valve Stenosis
D001022	Aortic Valve Insufficiency
D003251	Constriction, Pathologic
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D014694	Ventricular Outflow Obstruction

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation
D019616	Thoracic Surgical Procedures