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New treatment option for Aortic Stenosis
Official title Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
ClinicalTrials.gov ID: NCT05886517
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 to 120
You may be able to join if
- Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mmHg or jet velocity \> 4.0 m/s aortic valve...
- 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...
- High surgical risk (%, logES\>20%, EuroSCORE II \> 9 and STS score \> 8%)
You likely can't join 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...
See the full eligibility 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...
- 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Acquaviva delle Fonti, Bari, Italy
- Forlì, Emilia-Romagna, Italy
- Ravenna, Italy
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Acquaviva delle Fonti, Bari, Italy; Forlì, Emilia-Romagna, Italy; Ravenna, Italy; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.