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Recruiting NCT05886517

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

No phase Interventional Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transfemoral transcatheter aortic valve implementation.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: 75 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Transfemoral transcatheter aortic valve implementation
    ranscatheter aortic valve implantation, a percutaneous treatment for severe aortic valve stenosis, is increasingly performed worldwide. The pacemaker should be able to perform overdrive pacing which is essential to reduce cardiac output and transvalvular blood flow which are critical during balloon aortic valvuloplasty and valve deployment of the balloon- expandable valve. Minor adjustment may be needed for ideal positioning, but importantly this has to be done before valve implantation

Primary outcome measures

  • number of all cause death patients in 30 days following TAVI/total TAVI patients [Time frame: 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 3 centers
  • Ospedale Generale Regionale F Miulli — Acquaviva delle Fonti
  • AUSL Romagna Morgagni - Pierantoni Hospital — Forlì
  • Ospedale Santa Maria della Croci — Ravenna
Spain · 1 center
  • Hospital del Mar — Barcelona

Identifiers

NCT: NCT05886517 · TAVI at Home

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗