Actively Recruiting
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Led by AUSL Romagna Rimini · Updated on 2025-02-21
200
Participants Needed
4
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Senile degenerative aortic valve stenosis with echocardiography criteria: mean gradient > 40 mmHg or jet velocity > 4.0 m/s, aortic valve area (AVA) < 0.8 cm2 (or AVA index < 0.5 cm2/m2)
- Symptomatic with NYHA Functional Class >= II
- Age >= 75 years old
- Prohibitive surgical risk as determined by Heart Team using clinical criteria and Varc-2 consensus
- High surgical risk with logES > 20%, EuroSCORE II > 9, and STS score > 8%
- Porcelain aorta with heavy calcification or severe plaques preventing clamping
- Hostile chest due to severe skeletal abnormalities, previous surgery complications, severe radiation damage, or recurrent pleural effusions
- Frailty indicated by slowness, weakness, exhaustion, malnutrition, low BMI (< 20 Kg/m2), weight loss (> 5 kg/year), low serum albumin (< 3.5 g/dl), cognitive impairment, or dementia
- Severe liver disease or cirrhosis
- Patent internal mammary artery graft crossing midline or adherent to sternum
- Severe pulmonary hypertension
- Severe right ventricular dysfunction
- Transfemoral access allowed
- Signed informed consent
You will not qualify if you...
- TAVI in case of aortic valve bioprosthesis (valve-in-valve procedure)
- Contraindication to femoral access
- Bicuspid aortic valve
- Instrumental findings from angioTC indicating increased risk of complications, including severe left ventricle outflow tract or sub-annular calcification
- Conditions increasing risk of valve ring rupture
- Complex aortic plaques with risk of dissection
- Valvular ring-coronary ostia distance < 10 mm increasing coronary obstruction risk
- Severe aortic root dilation or aortic annulus sizes outside safe range for TAVI implantation
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Ospedale Generale Regionale F Miulli
Acquaviva delle Fonti, Bari, Italy
Actively Recruiting
2
AUSL Romagna Morgagni - Pierantoni Hospital
Forlì, Emilia-Romagna, Italy, 47121
Actively Recruiting
3
Ospedale Santa Maria della Croci
Ravenna, Italy, 48121
Actively Recruiting
4
Hospital del Mar
Barcelona, Spain
Actively Recruiting
Research Team
F
Fabio Tarantino, Medical Director
CONTACT
M
Miriam Compagnone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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