Status:
ENROLLING_BY_INVITATION
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
Lead Sponsor:
Centre Cardiologique du Nord
Collaborating Sponsors:
Henri Mondor University Hospital
Universita degli Studi di Genova
Conditions:
Prosthesis Survival
Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Eligibility:
All Genders
18-90 years
Brief Summary
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve im...
Detailed Description
The target population enrolled in the study includes patients with aortic-valve stenosis at risk to severe valve obstruction who have had TAVI or standard surgical procedure of their aortic valve with...
Eligibility Criteria
Inclusion
- Individuals enrolled in TAVI arm were required to have the predicted risk of operative mortality was ≥ 15% and/or a STS score of ≥ 10. A candidate who did not meet the STS score criteria of ≥ 10 was included in the study if a peer review by at least two surgeon investigators concluded and documented that the patient's predicted risk of operative mortality was ≥ 15%. For all group Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mm Hg or jet velocity \> 4.0 m/s or an aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2).
Exclusion
- • Patients with evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation.
- Blood dyscrasias as defined : leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 mg%), thrombocytopenia (platelet count \< 50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
- Need for emergency surgery for any reason.
- Hypertrophic cardiomyopathy with or without obstruction.
- Severe ventricular dysfunction with LVEF \< 20%.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel
- (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
- For TAVI arm Native aortic annulus size \< 18mm or 25mm as measured by echocardiogram.
- Subject was offered surgery but refused surgery.
- Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
- Renal insufficiency (creatinine \> 3.0mg/dL) and/or end stage renal disease requiring chronic
- dialysis.
- Life expectancy \< 12 months due to non-cardiac co-morbid conditions.
- For TAVI group significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal diameter 5 cm or greater), marked tortuosity, aortic arch atheroma, narrowing of the abdominal aorta with particular regard for calcification and surface irregularities, or severe "unfolding" and tortuosity of the thoracic aorta. This criteria were applicable for transfemoral patients only.
- For TAVI group Iliofemoral vessel characteristics that would preclude safe placement of 14F or 18F introducer
- For TAVI arm sheath such as severe calcification, severe tortuosity or vessels size diameter \< 7 mm for 22F
- Active bacterial endocarditis or other active infections.
- For TAVI arm bulky calcified aortic valve leaflets in close proximity to coronary ostia.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT05261204
Start Date
January 1 2013
End Date
December 31 2025
Last Update
March 5 2025
Active Locations (1)
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1
Francesco Nappi
Saint-Denis, France, 93200