Clinical trial NCT05536310: TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
Official title: Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: JenaValve Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 30-days post-index procedure
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Stroke
timeFrame: 30 days and 1 year
measure: Major vascular complications
timeFrame: 30 days
measure: Major and life-threatening bleeding
timeFrame: 30 days
measure: New conduction defects requiring permanent pacemaker
timeFrame: 30 days
measure: Acute kidney injury stage 2-3
timeFrame: 7 days
measure: New onset atrial fibrillation
timeFrame: 30 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
city: Köln
country: Germany
facility: University Hospital of Cologne Heart Center
city: Mainz
country: Germany
facility: University Hospital Mainz
Study officials:
affiliation: University Hospital of Cologne Heart Center
name: Stephan Baldus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johannes Gutenberg University Mainz
name: Hendrik Treede, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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.
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.