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

NCT ID: NCT05886517

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVI procedure

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.

Group Type: EXPERIMENTAL

Transfemoral transcatheter aortic valve implementation

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AUSL Romagna Rimini

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale Generale Regionale F Miulli

Acquaviva delle Fonti, Bari, Italy

Site Status: RECRUITING

AUSL Romagna Morgagni - Pierantoni Hospital

Forlì, Emilia-Romagna, Italy

Site Status: RECRUITING

Ospedale Santa Maria della Croci

Ravenna, , Italy

Site Status: RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Countries

Italy; Spain

Central Contacts

Fabio Tarantino, Medical Director

Role: CONTACT

fabio.tarantino@auslromagna.it

0543735132

Miriam Compagnone

Role: CONTACT

0543735132

Facility Contacts

Elia Orio Direttore

Role: primary

Fabio Tarantino, MD, MSc

Role: primary

fabio.tarantino@auslromagna.it

Caterina Cavazza, Direttore

Role: primary

Beatriz Vaquerizo

Role: primary

Other Identifiers

TAVI at Home

Identifier Type: -

Identifier Source: org_study_id