Transfemoral aortic valve replacement for high-risk patients without on-site surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of transfemoral transcatheter aortic valve implantation (TAVI) in patients with severe symptomatic aortic stenosis who are at prohibitive surgical risk and are treated in hospitals without on-site cardiac surgery. It is a single-arm, multicenter study that aims to enroll approximately 200 patients, starting with a pilot phase of 20 patients. The procedure will be performed by an expert operator team, and the outcomes will be assessed to determine the feasibility of TAVI in this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ospedale Generale Regionale F Miulli
  Acquaviva delle Fonti, Bari, Italy Recruiting
• AUSL Romagna Morgagni - Pierantoni Hospital
  Forlì, Emilia-Romagna, Italy Recruiting
• Ospedale Santa Maria della Croci
  Ravenna, Italy Recruiting
• Hospital del Mar
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Fabio Tarantino, Medical Director
• Email: fabio.tarantino@auslromagna.it
• Phone: 0543735132

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.