Clinical trial NCT05886517: Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Official title: Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evalutate all cause mortality at 30 days following TAVI
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: number of all cause death patients in 30 days following TAVI/total TAVI patients
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Generale Regionale F Miulli
state: Bari
city: Forli
country: Italy
facility: AUSL Romagna Morgagni - Pierantoni Hospital
state: Emilia Romagna
city: Ravenna
country: Italy
facility: Ospedale Santa Maria della Croci
city: Barcellona
country: Spain
facility: Hospital del Mar
Study officials:
References: