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

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID: NCT05886517
Run by: AUSL Romagna Rimini
People needed: 200
Starts: 2023-05-01
Expected to finish: 2026-04-01
Last updated by the study team: 2025-02-21

Who can join

Age: 75 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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