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ENROLLING BY INVITATION

NCT05261204

Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

Sponsor: Centre Cardiologique du Nord

View on ClinicalTrials.gov

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 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.

Official title: Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Operation for Aortic-Valve Stenosis in Patients at Risk to Severe Valve Obstruction.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2013-01-01

Completion Date

2025-12-31

Last Updated

2025-03-05

Healthy Volunteers

Not specified

Conditions

Prosthesis Survival Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Interventions

DEVICE

Transcatheter Aortic Valve Implantation

Patients who are deemed receive TAVI first underwent evaluation of their peripheral arteries before the procedure, in order to separate those eligible for transfemoral placement (TFP) from those who would require transapical placement. Technological advances achieved in the new platforms for the treatment of SHD have allowed the use of reduced size catheters and sheaths in the new armamentarium, favoring the TFP technique. The transcatheter valve (TV) is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ventricular pacing. The delivery system i traverses the aorta retrograde over a guidewire from its point of insertion in the femoral artery during the use of TFP. Before balloon inflation, the valve and balloon are collapsed on the catheter and fit within the sheath. After balloon inflation, the calcified native valve is replaced by the expanded TV

PROCEDURE

Bioprothesis

The bioprosthesis is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

PROCEDURE

Sutureless

The sutureless is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

Inclusion Criteria: * 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 Criteria: * • 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.

Locations (1)

Francesco Nappi

Saint-Denis, France