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

NCT05536310 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLIN-0099
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Keywords

Trilogy; Aortic Valve Disease; Transcatheter aortic valve replacement (TAVR); Aortic Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Mortality from any cause in patients receiving TAVI for AR or AS

  30-days post-index procedure

Secondary Outcomes (7)

• Death

  1 year

• Stroke

  30 days and 1 year

• Major vascular complications

  30 days

• Major and life-threatening bleeding

  30 days

• New conduction defects requiring permanent pacemaker

  30 days

Study Arms (1)

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

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

TAVI with the JenaValve Trilogy Heart Valve System

Trilogy TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JenaValve Technology, Inc.: lead

Study Sites (3)

Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

University Hospital of Cologne Heart Center

Cologne, 50937, Germany

Location

University Hospital Mainz

Mainz, 55131, Germany

Location

Related Publications (7)

• 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.

  PMID: 28314623 BACKGROUND

• Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.

  PMID: 28298458 BACKGROUND

• Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

  PMID: 12831818 BACKGROUND

• Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.

  PMID: 34556282 BACKGROUND

• Treede H, Rastan A, Ferrari M, Ensminger S, Figulla HR, Mohr FW. JenaValve. EuroIntervention. 2012 Sep;8 Suppl Q:Q88-93. doi: 10.4244/EIJV8SQA16.

  PMID: 22995119 BACKGROUND

• Poschner T, Werner P, Kocher A, Laufer G, Musumeci F, Andreas M, Russo M. The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease. Future Cardiol. 2022 Feb;18(2):101-113. doi: 10.2217/fca-2021-0065. Epub 2021 Oct 14.

  PMID: 34647465 BACKGROUND

• Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.

  PMID: 34317595 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Stephan Baldus, MD

  University Hospital of Cologne Heart Center

  PRINCIPAL INVESTIGATOR

• Hendrik Treede, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinny Podichetty, Vice President: Clinical & Med Affairs

CONTACT

949-767-2110; podichetty@jenavalve.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)