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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Constriction, Pathologic; Aortic Valve Stenosis With Insufficiency; Cardiovascular Diseases in Old Age; Aortic Stenosis, Severe; Aortic Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation (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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

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

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
    • Contact: Sarah Symank; Phone Number: +49 (0)5731-973442; Email: ssymank@hdz-nrw.de
    • Principal Investigator: Tanja Rudolph, MD
  • Köln, Germany, 50937
    • University Hospital of Cologne Heart Center
    • Contact: Iris Berg; Phone Number: +49 221 4784191; Email: iris.berg@uk-koeln.de
  • Mainz, Germany, 55131
    • University Hospital Mainz
    • Contact: Phone Number: 06131 17-3208
    • Principal Investigator: Hendrik Treede, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); TAVI with the JenaValve Trilogy Heart Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Reported death in patients participating in TAVIS Registry	1 year
Stroke	Reported stroke in patients participating in TAVIS Registry	30 days and 1 year
Major vascular complications	Reported vascular complications in patients participating in TAVIS Registry	30 days
Major and life-threatening bleeding	Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry	30 days
New conduction defects requiring permanent pacemaker	Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry	30 days
Acute kidney injury stage 2-3	Reported kidney injury complications in patients participating in TAVIS Registry	7 days
New onset atrial fibrillation	Reported new onset atrial fibrillation in patients participating in TAVIS Registry	30 days

Collaborators and Investigators

• Sponsor: JenaValve Technology, Inc.
• Investigators: Principal Investigator: Stephan Baldus, MD, University Hospital of Cologne Heart Center; Principal Investigator: Hendrik Treede, MD, Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Valve Disease; Transcatheter aortic valve replacement (TAVR); Trilogy; Aortic Valve Regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Cardiovascular Diseases; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic; Heart Defects, Congenital; Heart Valve Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction
• Other Study ID Numbers: CLIN-0099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes