Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Key facts
- Who runs it
- AUSL Romagna Rimini
- Where
- Acquaviva delle Fonti, Forlì, and Ravenna, ItalySee the 3 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 May 2023
- Planned end
- Apr 2026
- Type of study
- Interventional
- Treatments tested
- Transfemoral transcatheter aortic valve implementation
- Record updated
- 21 February 2025
Who can take part
- Age
- 75 years to 120 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Tavi in case of aortic valve bioprosthesis (TAVI valve-in valve)
- controindication to femoral access
- Bicuspid aortic valve
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 75 and 120 years old?
Where in Italy
Also in 1 other country, 1 site
- Ospedale Generale Regionale " F.Miulli "Acquaviva delle Fonti, ItalyContact: Elia Orio DirettoreTaking people
- AUSL Romagna Morgagni - Pierantoni HospitalForlì, ItalyContact: Fabio Tarantino, MD, MScTaking people
- Ospedale Santa Maria della CrociRavenna, ItalyContact: Caterina Cavazza, DirettoreTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- TAVI procedureTreatment being tested
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.
Treatment: Transfemoral transcatheter aortic valve implementation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT05886517, who can take part
- Record updated
- 21 February 2025