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

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transfemoral transcatheter aortic valve implementation
Sponsored by
AUSL Romagna Rimini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

75 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AUSL Romagna Morgagni - Pierantoni HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAVI procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

number of all cause death patients in 30 days following TAVI/total TAVI patients
the simple size calculation is based on the primary endpoint mortality at 30 days. Considering a standard incidence of 6-7% 200 patients will be needed to demonstrate, wuth an alpha error of 5% the non inferiority of the alternative treatment compared to the standard considering a non inferiory margin of 3% such as to exclude mortaluty values higher than 10%, in relation at the upper limit of the 90% confidence interval calculated with the exact method of clopper and Pearson.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2023
Last Updated
May 23, 2023
Sponsor
AUSL Romagna Rimini
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1. Study Identification

Unique Protocol Identification Number
NCT05886517
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AUSL Romagna Rimini

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Evalutate all cause mortality at 30 days following TAVI
Masking
None (Open Label)
Masking Description
Nr. of all cause death patients at 30 days following TAVI/total patients
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVI procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transfemoral transcatheter aortic valve implementation
Intervention Description
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 Measure Information:
Title
number of all cause death patients in 30 days following TAVI/total TAVI patients
Description
the simple size calculation is based on the primary endpoint mortality at 30 days. Considering a standard incidence of 6-7% 200 patients will be needed to demonstrate, wuth an alpha error of 5% the non inferiority of the alternative treatment compared to the standard considering a non inferiory margin of 3% such as to exclude mortaluty values higher than 10%, in relation at the upper limit of the 90% confidence interval calculated with the exact method of clopper and Pearson.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Tarantino, Medical Director
Phone
0543735132
Email
fabio.tarantino@auslromagna.it
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Compagnone
Phone
0543735132
Facility Information:
Facility Name
AUSL Romagna Morgagni - Pierantoni Hospital
City
Forli
State/Province
Emilia Romagna
ZIP/Postal Code
47121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Tarantino, MD, MSc
Email
fabio.tarantino@auslromagna.it
First Name & Middle Initial & Last Name & Degree
Fabio P Tarantino, MD
First Name & Middle Initial & Last Name & Degree
Miriam Compagnone, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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