Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

Aortic Stenosis Clinical Trial

Official title:

Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886517
• Other study ID #: TAVI at Home
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2023
• Source: AUSL Romagna Rimini
• Contact: Fabio Tarantino, Medical Director
• Phone: 0543735132
• Email: fabio.tarantino[@]auslromagna.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by expert operator team, in patients with prohibitive surgical risk. For the pilot phase, 20 patients will be enrolled. For whole study, all consecutive patients undergoing TAVI in center without CS on site will be enrolled to reach a number of about 200 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• Transfemoral transcatheter aortic valve implementation
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

Locations

Country	Name	City	State
Italy	AUSL Romagna Morgagni - Pierantoni Hospital	Forli	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
AUSL Romagna Rimini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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