Aortic StenosisNCT05886517
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
A study testing Transfemoral transcatheter aortic valve implementation in people with Aortic Stenosis, run by AUSL Romagna Rimini at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 120 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transfemoral transcatheter aortic valve implementation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 May 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Miriam Compagnone contact
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Ospedale Generale Regionale F Miulli
Acquaviva delle Fonti, Bari
Elia Orio Direttore
Elia Iorio
- Recruiting
AUSL Romagna Morgagni - Pierantoni Hospital
Forlì, Emilia-Romagna, 47121
Fabio Tarantino, MD, MSc, fabio.tarantino@auslromagna.it
Fabio P Tarantino, MD
- Recruiting
Ospedale Santa Maria della Croci
Ravenna, 48121
Caterina Cavazza, Direttore
Caterina Cavazza
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona
Beatriz Vaquerizo
Beatriz Vaquerizo
About this study
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
- Aortic Stenosis
- Being tested
- Transfemoral transcatheter aortic valve implementation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfemoral transcatheter aortic valve implementationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| TAVI procedure | Experimental | 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. Receives: Device: Transfemoral transcatheter aortic valve implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 May 2023
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evalutate all cause mortality at 30 days following TAVI
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886517
- Sponsor's protocol ID
- TAVI at Home
- Status last verified
- Feb 2025
- First submitted
- 12 May 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- TAVI at Home
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evalutate all cause mortality at 30 days following TAVI
| Arm | Type | Receives |
|---|---|---|
| TAVI procedure | Experimental | Device: Transfemoral transcatheter aortic valve implementationPatients 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. |
Who may qualify
- Ages
- 75 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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%)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfemoral transcatheter aortic valve implementationranscatheter 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 | Device | TAVI procedure |
Primary outcome
number of all cause death patients in 30 days following TAVI/total TAVI patients
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Compagnone contact
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfemoral transcatheter aortic valve implementation in people with Aortic Stenosis, run by AUSL Romagna Rimini at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Tarantino, Medical Director (0543735132, fabio.tarantino@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of all cause death patients in 30 days following TAVI/total TAVI patients (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.