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

Sponsor
JenaValve Technology, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05536310
Collaborator
(none)
600
3
60
200
3.3

Study Details

Study Description

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
600 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality [30-days post-index procedure]

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

Secondary Outcome Measures

  1. Death [1 year]

    Reported death in patients participating in TAVIS Registry

  2. Stroke [30 days and 1 year]

    Reported stroke in patients participating in TAVIS Registry

  3. Major vascular complications [30 days]

    Reported vascular complications in patients participating in TAVIS Registry

  4. Major and life-threatening bleeding [30 days]

    Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry

  5. New conduction defects requiring permanent pacemaker [30 days]

    Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry

  6. Acute kidney injury stage 2-3 [7 days]

    Reported kidney injury complications in patients participating in TAVIS Registry

  7. New onset atrial fibrillation [30 days]

    Reported new onset atrial fibrillation in patients participating in TAVIS Registry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen Bad Oeynhausen Germany 32545
2 University Hospital of Cologne Heart Center Köln Germany 50937
3 University Hospital Mainz Mainz Germany 55131

Sponsors and Collaborators

  • JenaValve Technology, Inc.

Investigators

  • Principal Investigator: Stephan Baldus, MD, University Hospital of Cologne Heart Center
  • Principal Investigator: Hendrik Treede, MD, Johannes Gutenberg University Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
JenaValve Technology, Inc.
ClinicalTrials.gov Identifier:
NCT05536310
Other Study ID Numbers:
  • CLIN-0099
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by JenaValve Technology, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2022