Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

Enrolling by invitation

Conditions studied: Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result

In brief

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 implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS. Any potential failure of the devices in question will be thoroughly investigated by means of CT scanning and biomechanical computational modelling, utilising finite element analysis (FEA).

Key facts

Study ID: NCT05261204
Run by: Centre Cardiologique du Nord
People needed: 4000
Starts: 2013-01-01
Expected to finish: 2029-05-31
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

• 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.

Where it is running

Francesco Nappi — Saint-Denis, France, France

Full record on ClinicalTrials.gov

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