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

Aortic Valve Stenosis Clinical Trial

— TAVIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536310
• Other study ID #: CLIN-0099
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: October 2027

Study information

• Verified date: January 2023
• Source: JenaValve Technology, Inc.
• Contact: Vinny Podichetty, Vice President: Clinical & Med Affairs
• Phone: 949-767-2110
• Email: podichetty[@]jenavalve.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 2027
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Transcatheter Aortic Valve Implantation (TAVI)
TAVI with the JenaValve Trilogy Heart Valve System

Locations

Country	Name	City	State
Germany	Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen	Bad Oeynhausen
Germany	University Hospital of Cologne Heart Center	Köln
Germany	University Hospital Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
JenaValve Technology, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Mortality from any cause in patients receiving TAVI for AR or AS	30-days post-index procedure
Secondary	Death	Reported death in patients participating in TAVIS Registry	1 year
Secondary	Stroke	Reported stroke in patients participating in TAVIS Registry	30 days and 1 year
Secondary	Major vascular complications	Reported vascular complications in patients participating in TAVIS Registry	30 days
Secondary	Major and life-threatening bleeding	Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry	30 days
Secondary	New conduction defects requiring permanent pacemaker	Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry	30 days
Secondary	Acute kidney injury stage 2-3	Reported kidney injury complications in patients participating in TAVIS Registry	7 days
Secondary	New onset atrial fibrillation	Reported new onset atrial fibrillation in patients participating in TAVIS Registry	30 days