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

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

This study is testing if a new heart valve procedure can safely help high-risk patients with severe aortic stenosis who are treated in hospitals without heart surgery available.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 75 Years to 120 Years
• Sex: All
• Sponsor: AUSL Romagna Rimini (Academic / other)
• Locations: 4 sites (Acquaviva delle Fonti, Bari and 3 other locations)
• Trial ID: NCT05886517 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 75 and older with symptomatic severe aortic valve stenosis and prohibitive surgical risk.

Not a fit: Patients who are not at prohibitive surgical risk or those with conditions that do not meet the study's inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for high-risk patients suffering from severe aortic stenosis.

How similar studies have performed: Other studies have shown success with similar approaches in treating high-risk patients with aortic stenosis, indicating a promising avenue for this intervention.

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.

Where this trial is running

Acquaviva delle Fonti, Bari and 3 other locations

• 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

Conditions Aortic Stenosis