VANTAGE Trial: Evaluation of TAVR using the NAVITOR* valve in a global investigatio
- Conditions
- Aortic valve replacementHeartfailure10046973
- Registration Number
- NL-OMON51939
- Lead Sponsor
- Abbott Medical Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. Subject who is judged by a heart team, including a cardiac surgeon, to be
appropriate for
transcatheter heart valve intervention therapy, and is deemed to be at
intermediate or low risk
for open surgical aortic valve replacement (i.e., heart team estimates
risk of surgical mortality
< 7% at 30 days, considering the Society of Thoracic Surgeons (STS)
risk score, overall
clinical status, and other clinical co-morbidities unmeasured by the
risk calculator *)
2. New York Heart Association (NYHA) Functional Classification of II, III, or
IV *
3. Subject is of legal age for consent in the host country
4. Subject has been informed of the nature of the trial, agrees to its
provisions and has provided
written informed consent as approved by the Ethics Committee (EC) of
the respective clinical
site.
5. Able and willing to return for required follow-up visits and assessments
6. Degenerative aortic valve stenosis with echo-derived criteria, defined as:
aortic valve
area (AVA) of <= 1.0 cm2 (or indexed EOA <= 0.6 cm2/m2) AND either mean
gradient >=40
mmHg or peak jet velocity >= 4.0 m/s or doppler velocity index (DVI)
<=0.25. The
echocardiogram supporting the qualifying AVA baseline measurement must
be performed
within 90 days prior to informed consent) *
7. Aortic annulus diameter of 19*30 mm and ascending aorta diameter of 26-44 mm
for the
specified valve size listed in the IFU, as measured by CT (systolic
phase) conducted within 12
months prior to informed consent.
* Criterion not applicable for valve-in-valve cohort
1. Pregnant or nursing subjects and those who plan pregnancy during the
clinical investigation
follow-up period. A pregnancy test is required for all women of
childbearing potential.
2. Need for emergency surgery for any reason
3. Life expectancy is less than 2 years in the opinion of the Investigator
4. Presence of other anatomic or comorbid conditions, or other medical, social,
or psychological
conditions that, in the investigator*s opinion, could limit the
subject*s ability to participate in the
clinical trial or to comply with follow up requirements, or impact the
scientific soundness of the
clinical trial results
5. Incapacitated individuals, defined as persons who are mentally ill, mentally
handicapped,
individuals with severe dementia or individuals without legal authority
6. Individuals who are unable to read or write
7. Currently participating in an investigational drug or device study that has
not reached the
primary endpoint or may confound the results of this trial
8. Evidence of an acute myocardial infarction [defined as:ST-segment elevation
myocardial
infarction (STEMI) or non-ST-segment elevation myocardial infarction
(NSTEMI) with acute
ischemia symptoms and troponin elevation] within 30 days prior to index
procedure
9. Untreated clinically significant coronary artery disease requiring
revascularization
10. Any percutaneous coronary or peripheral interventional procedure performed
within 30 days
prior (except pacemaker or implantable cardioverter defibrillator (ICD)
implant) to index
procedure or planned within 30 days following the index procedure.
11. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb <
9 g/dL),
thrombocytopenia (platelet count <50,000 cells/mm³); history of
bleeding diathesis or
coagulopathy
12. Refuses blood products
13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence,
or mechanical
hemodynamic support
14. Hemodynamic instability requiring inotropic support or mechanical heart
assistance
15. Hypertrophic cardiomyopathy with obstruction
16. Active peptic ulcer or upper GI bleeding within 3 months prior to index
procedure that would
preclude anti-coagulation
17. Known intolerance, hypersensitivity, or contraindication, including
subjects that meet any of the
following conditions:
a. Subjects who cannot take any antiplatelets or anticoagulants #,
b. Subjects who have sensitivity to contrast media which cannot be adequately
premedicated,
c. Subjects who have known hypersensitivity to nitinol (nickel or titanium), or
d. Subjects who have clinical contraindication that precludes contrast CT
imaging
# Note: Subjects who can take either an antiplatelet or anticoagulant
therapy post-procedure
will be eligible.
18. Recent (within 6 months prior to index procedure date) cerebrovascular
accident (CVA) or a
transient ischemic attack (TIA)
19. Renal insufficiency (creatinine > 3.0 mg/dL or eGFR <30 ml/min/1.73m2)
and/or end
stage renal disease requiring chronic dialysis
20. Active bacterial endocarditis within 6 months prior to the index procedure
21. A positive COVID-19 test within 30 days prior to the index procedure
22. Liver failure (Child-Pugh class B or C)
23. Subjects with atrial fibrillatio
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a composite of all-cause mortality or disabling stroke<br /><br>at 12 months. </p><br>
- Secondary Outcome Measures
Name Time Method