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

Not yet recruiting

• Conditions: Constriction, Pathologic; Ventricular Outflow Obstruction; Heart Valve Diseases; Aortic Valve Stenosis; Aortic Valve Regurgitation; Aortic Valve Disease; Aortic Stenosis, Severe; Aortic Valve Stenosis With Insufficiency; Cardiovascular Diseases in Old Age
• Interventions: Device: Transcatheter Aortic Valve Implantation (TAVI)

• Registration Number: NCT05536310
• Lead Sponsor: JenaValve Technology, Inc.

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.

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11
• Study Start: 2023-03
• Primary Completion: 2023-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trilogy TAVI	Transcatheter Aortic Valve Implantation (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)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University Hospital of Cologne Heart Center; 🇩🇪 Köln, Germany

University Hospital Mainz; 🇩🇪 Mainz, Germany

Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany