Transfemoral Transcatheter Aortic Valve Implementation at... | NCT05886517

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAVI procedure	Experimental	Patients will be evaluated at baseline to access their eligibility for the procedure. The day of TAVI patients will be prepared for the procedures as the institution's standard practice for an invasive percutaneous endovascular procedure. During the pre hospital discharge period, patients will be monitored and will receive standard post-procedure care as judged appropriate by PI. At 30 days from the procedure a Fu visit will be made in order to access survival and adverse clinical events.	Device: Transfemoral transcatheter aortic valve implementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transfemoral transcatheter aortic valve implementation	Device	ranscatheter aortic valve implantation, a percutaneous treatment for severe aortic valve stenosis, is increasingly performed worldwide. The pacemaker should be able to perform overdrive pacing which is essential to reduce cardiac output and transvalvular blood flow which are critical during balloon aortic valvuloplasty and valve deployment of the balloon- expandable valve. Minor adjustment may be needed for ideal positioning, but importantly this has to be done before valve implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of all cause death patients in 30 days following TAVI/total TAVI patients	the simple size calculation is based on the primary endpoint mortality at 30 days. Considering a standard incidence of 6-7% 200 patients will be needed to demonstrate, wuth an alpha error of 5% the non inferiority of the alternative treatment compared to the standard considering a non inferiory margin of 3% such as to exclude mortaluty values higher than 10%, in relation at the upper limit of the 90% confidence interval calculated with the exact method of clopper and Pearson.	4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient > 40 mmHg or jet velocity > 4.0 m/s aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2)
Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class > = II
Age >= 75 years old
Patients with prohibitive risk established in the Heart Team and defined on the basis of the following clinica instrument criteria according with the Varc-2 consensus.
High surgical risk (%, logES>20%, EuroSCORE II > 9 and STS score > 8%)
Porcelain aorta (heavy circumferential calcification or severe atheromatous plaques that do not allow clamping.
Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, complications form to previous surgery, evidence of severe radiotion damege, history of multiple recurrent pleural effusions causing internal adhesions.
Fragilty (slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence, BMI < 20 Kg/m2 and or weight loss 5 kg/year, serum albumin < 3,5 g/dl, cognitive impairment or dementia)
Severe liver disease/cirrosis
Presence of a patent graft of an internal mammary artery crossing mildline and/or adherent to posterior table of sternum
Severe pulmoary hypertension
Severe right ventricular dysfunction
Transfemoral access allowed
Signature of informed consent

Exclusion Criteria:

Tavi in case of aortic valve bioprosthesis (TAVI valve-in valve)
controindication to femoral access
Bicuspid aortic valve
Instrumental characteristics, evaluated by angioTC, associated with an increased risk of major complications: severe left ventricle outflow tract or sub annular calcification, condition associated with an increased risk of rupture of the valve ring, presence of complex aortic plaques correlated with the possibility of dissection, valvular ring-coronary ostia distance < 10 mm associated with a high probability of coronary obstruction, severe aortic root dilatation or out of range aortic annulus diameters for TAVI are not complatible for safe valve implatation.

Name	Role	Phone	Extension	Email
Fabio Tarantino, Medical Director	Contact	0543735132		fabio.tarantino@auslromagna.it
Miriam Compagnone	Contact	0543735132

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction