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

Sponsor

AUSL Romagna Rimini (Other)

Overall Status

Recruiting

CT.gov ID

NCT05886517

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis	Device: Transfemoral transcatheter aortic valve implementation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Evalutate all cause mortality at 30 days following TAVIEvalutate 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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAVI procedure 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.	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

Arm

Intervention/Treatment

Experimental: TAVI procedure

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.

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

Outcome Measures

Primary Outcome Measures

number of all cause death patients in 30 days following TAVI/total TAVI patients [4 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AUSL Romagna Morgagni - Pierantoni Hospital	Forli	Emilia Romagna	Italy	47121

Sponsors and Collaborators

AUSL Romagna Rimini

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AUSL Romagna Rimini

ClinicalTrials.gov Identifier:

NCT05886517

Other Study ID Numbers:

TAVI at Home

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aortic Valve Stenosis

Study Results

No Results Posted as of Jun 2, 2023