Aortic StenosisTRACS-PRIMENCT07604402
TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery
A study testing Transcatheter Aortic Valve Implantation in people with Aortic Stenosis, run by University Hospital of Ferrara at 11 sites in Italy.
Trial summary
TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,612 participants
- Where
- 11 sitesItaly
- Study dates
- 25 May 2026to 25 May 2034
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe aortic stenosis
- Indication to TAVI confirmed by the Heart Team
- AND one of the following enrichment criteria:
- Prohibitive operative risk
- High surgical risk as defined as STS score >8%
- Porcelain aorta or severely atherosclerotic aorta
Show all 12Show fewer
- Frailty/Reduced physical performance
- Severe liver disease/cirrhosis
- Hostile chest and/or internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
- Severe pulmonary hypertension and/or severe right ventricular dysfunction
- Age ≥85 years
- Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk/benefit profile appropriate for inclusion in the protocol.
Who cannot join
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Non-cardiovascular comorbidity reducing life expectancy to <1 year
- Any factor precluding 1-year follow-up
- Refusal of informed consent
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
Ospedale "L. Bonomo" - Andria - ASL Barletta Andria Trani
Andria
Claudio Larosa, MD, 0883 299111, larosa.cld@gmail.com
- Recruiting
Ospedale San Donato
Arezzo
Matteo Reccia, MD, 0575 2551, matteo.reccia.21@gmail.com
- Recruiting
Ospedale Maggiore CA Pizzardi, AUSL di Bologna
Bologna
Gianni Casella, MD, 051 6478111, casella.gianni@gmail.com
- Not yet recruiting
Azienda Ospedaliero Universitaria di Ferrara
Ferrara
Gianluca, Campo, 0532236269 ext. +39, cmpglc@unife.it
- Recruiting
Ospedale Misericordia di Grosseto
Grosseto
Andrea Picchi, MD, 0564 485111, andre.picchi@gmail.com
- Recruiting
Ospedale Regionale San Salvatore
L’Aquila
Livio Giuliani, MD, 0862 3681, lvgiuliani@gmail.com
- Recruiting
Ospedale di Mirano
Mirano
Salvatore Saccà, 041/5794158 ext. +39, salvatore.sacca@aulss3.veneto.it
- Recruiting
Ospedale Santa Maria delle Croci, AUSL Romagna
Ravenna
Carolina Moretti, MD, 0544 285111, caropilla@gmail.com
- Recruiting
Ospedale degli Infermi di Rimini
Rimini
Caterina Cavazza, MD, 0541 705111, caterina.cavazza82@gmail.com
- Recruiting
Ospedale Ss. Giovanni e Paolo
Venezia
Giuseppe Grassi, 041 529 4111 ext. +39, giuseppe.grassi@aulss3.veneto.it
- Recruiting
Ospedale Sacro Cuore Don Calabria, Negrar
Verona
Giulio Molon, MD, 045.601.31.11, giulio.molon@sacrocuore.it
About this study
Official title: TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery Broadened Access
TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.
Read the detailed description
Severe symptomatic aortic stenosis is a common and clinically relevant condition in elderly and high-risk patients. Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with an appropriate indication after multidisciplinary Heart Team evaluation. As the number of patients eligible for TAVI continues to increase, access to timely treatment may be limited by the availability and capacity of hospitals with on-site cardiac surgery. Historically, TAVI has generally been performed in centers with on-site cardiac surgery because of the potential need for emergency surgical management of rare but severe procedural complications. However, advances in patient selection, pre-procedural imaging, device technology, procedural planning, and operator experience have reduced the frequency of complications requiring emergent cardiac surgery. These developments have raised the question of whether selected patients can safely undergo TAVI in appropriately organized centers without on-site cardiac surgery, provided that strict procedural safeguards are in place. The TRACS study was previously conducted as a pilot randomized clinical project to evaluate this strategy. That study supported the feasibility and safety of performing TAVI in selected centers without on-site cardiac surgery under a structured protocol, experienced operators, multidisciplinary patient selection, and predefined safety procedures. TRACS-PRIME is designed to extend this experience in a larger and more generalizable randomized trial. TRACS-PRIME is a prospective, randomized, multicenter, open-label trial with blinded adjudication of clinical outcomes. Patients with severe aortic stenosis and an indication for TAVI confirmed by a multidisciplinary Heart Team will be considered for enrollment. Before randomization, patients will undergo standard clinical, echocardiographic, laboratory, coronary, and computed tomography evaluation to confirm eligibility, assess procedural feasibility, and identify factors that may increase procedural risk. Eligible patients who provide written informed consent will be randomized to one of two treatment strategies. In the experimental strategy, TAVI will be performed in a participating center without on-site cardiac surgery. These centers must have experienced TAVI operators, advanced cardiac imaging, established collaboration with a referral cardiac surgery department, and predefined procedures for rapid transfer in case of complications. In the control strategy, TAVI will be performed in a center with on-site cardiac surgery. In both groups, the procedure will be performed according to current guidelines, local standards of care, and the judgment of experienced TAVI operators. The study is intended to evaluate whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery in terms of clinical efficacy and safety at 1 year. Clinical events will be collected prospectively and adjudicated by an independent Clinical Events Committee blinded to treatment allocation. Patient safety and trial conduct will be monitored by an independent Data Safety Monitoring Board. After hospital discharge, participants will undergo structured clinical follow-up to assess clinical status, adverse events, hospitalizations, and other relevant outcomes. The overall aim of TRACS-PRIME is to determine whether a carefully controlled strategy of TAVI in selected centers without on-site cardiac surgery can preserve patient safety while potentially improving access to timely treatment for patients with severe aortic stenosis.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation
- Keywords
- TAVI, on-site cardiac surgery
- 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.
Transcatheter Aortic Valve ImplantationProcedure or surgery
Transcatheter aortic valve implantation is performed as the study procedure in patients with severe aortic stenosis and an indication for TAVI confirmed by the multidisciplinary Heart Team. The procedure is performed according to current guidelines and institutional standards by experienced TAVI operators. In this trial, the intervention is evaluated according to the setting in which it is performed: either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| TAVI in center without on-site cardiac surgery | Experimental | Participants assigned to this arm will undergo transcatheter aortic valve implantation in a participating center without on-site cardiac surgery. The procedure will be performed by experienced TAVI operators according to current guidelines, institutional standards, and pre-procedural Heart Team assessment. Participating centers must have appropriate imaging, procedural expertise, and predefined pathways for rapid transfer to a referral cardiac surgery center if needed. Receives: Procedure: Transcatheter Aortic Valve Implantation |
| TAVI in center with on-site cardiac surgery | Active comparator | Participants assigned to this arm will undergo transcatheter aortic valve implantation in a center with on-site cardiac surgery. After randomization, patients will be referred to the collaborating cardiac surgery center and treated according to the local waiting list and standard clinical practice. The procedure will be performed by experienced TAVI operators in accordance with current guidelines, institutional standards, and pre-procedural Heart Team assessment. Receives: Procedure: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality, all stroke, or hospitalization for procedure- or valve-related causes
The primary clinical efficacy outcome is a composite endpoint defined as the occurrence of any of the following events within 1 year after randomization: death from any cause, any stroke, or hospitalization related to the TAVI procedure or to the implanted valve. This endpoint will be assessed prospectively and adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
Measured: 1-year
Secondary outcomes (10)
All-cause death
Measured: 1-year
Cardiovascular death
Measured: 1-year
All stroke
Measured: 1-year
Ischemic stroke
Measured: 1-year
Haemorrhagic stroke
Measured: 1-year
Stroke not otherwise specified
Measured: 1-year
Procedure-related or valve-related hospitalization
Hospitalization for procedure-related or valve-related causes is defined according to VARC-3 criteria. It includes any hospital admission, or prolongation of an index hospitalization, primarily due to complications or clinical events related to the TAVI procedure, vascular access, implanted valve, or valve function, including valve dysfunction, valve-related complications, or other clinically relevant procedure-associated adverse events.
Measured: 1-year
Other cardiovascular hospitalization
Measured: 1-year
Myocardial infarction
Measured: 1-year
Aortic bioprosthetic valve dysfunction
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 May 2026
- Primary completion25 May 2030 (estimated)
- Study completion25 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two parallel treatment groups. In the experimental group, TAVI is performed in a center without on-site cardiac surgery. In the control group, TAVI is performed in a center with on-site cardiac surgery. Patients in both groups are managed according to current standards of care and followed prospectively for clinical and safety outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Consorzio Futuro in Ricerca
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Gianluca Campo, MD, Principal investigator, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604402
- Sponsor's protocol ID
- 635/2025/Sper/AOUFe
- Acronym
- TRACS-PRIME
- Status last verified
- Aug 2026
- First submitted
- 17 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be made available upon reasonable request after publication of the main study results. Requests will be reviewed by the Steering Committee and will be considered based on scientific merit, feasibility, participant privacy, and compliance with applicable ethical and regulatory requirements. Any data sharing will require appropriate approvals and a data use agreement.
Publications
Iannopollo G, Cocco M, Leone A, Sacca S, Mangino D, Picchi A, Reccia MR, Fineschi M, Meliga E, Audo A, Nobile G, Tumscitz C, Penzo C, Saia F, Rubboli A, Moretti C, Vignali L, Niccoli G, Cimaglia P, Rognoni A, Aschieri D, Iaccarino D, Ottani F, Cavazza C, Varbella F, Secco GG, Bolognese L, Limbruno U, Guiducci V, Campo G, Casella G. Transcatheter aortic-valve implantation with or without on-site cardiac surgery: The TRACS trial. Am Heart J. 2025 Feb;280:7-17. doi: 10.1016/j.ahj.2024.10.019. Epub 2024 Nov 4.
PubMed 39505122
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery Broadened Access
- ClinicalTrials.gov ID
- NCT07604402
- Acronym / sponsor ID
- TRACS-PRIME / 635/2025/Sper/AOUFe
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, on-site cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,612 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Consorzio Futuro in Ricerca
- Study start
- 25 May 2026 (actual)
- Primary completion
- 25 May 2030 (estimated)
- Study completion
- 25 May 2034 (estimated)
- First posted
- 22 May 2026 (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.
TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.
Detailed description
Severe symptomatic aortic stenosis is a common and clinically relevant condition in elderly and high-risk patients. Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with an appropriate indication after multidisciplinary Heart Team evaluation. As the number of patients eligible for TAVI continues to increase, access to timely treatment may be limited by the availability and capacity of hospitals with on-site cardiac surgery. Historically, TAVI has generally been performed in centers with on-site cardiac surgery because of the potential need for emergency surgical management of rare but severe procedural complications. However, advances in patient selection, pre-procedural imaging, device technology, procedural planning, and operator experience have reduced the frequency of complications requiring emergent cardiac surgery. These developments have raised the question of whether selected patients can safely undergo TAVI in appropriately organized centers without on-site cardiac surgery, provided that strict procedural safeguards are in place. The TRACS study was previously conducted as a pilot randomized clinical project to evaluate this strategy. That study supported the feasibility and safety of performing TAVI in selected centers without on-site cardiac surgery under a structured protocol, experienced operators, multidisciplinary patient selection, and predefined safety procedures. TRACS-PRIME is designed to extend this experience in a larger and more generalizable randomized trial. TRACS-PRIME is a prospective, randomized, multicenter, open-label trial with blinded adjudication of clinical outcomes. Patients with severe aortic stenosis and an indication for TAVI confirmed by a multidisciplinary Heart Team will be considered for enrollment. Before randomization, patients will undergo standard clinical, echocardiographic, laboratory, coronary, and computed tomography evaluation to confirm eligibility, assess procedural feasibility, and identify factors that may increase procedural risk. Eligible patients who provide written informed consent will be randomized to one of two treatment strategies. In the experimental strategy, TAVI will be performed in a participating center without on-site cardiac surgery. These centers must have experienced TAVI operators, advanced cardiac imaging, established collaboration with a referral cardiac surgery department, and predefined procedures for rapid transfer in case of complications. In the control strategy, TAVI will be performed in a center with on-site cardiac surgery. In both groups, the procedure will be performed according to current guidelines, local standards of care, and the judgment of experienced TAVI operators. The study is intended to evaluate whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery in terms of clinical efficacy and safety at 1 year. Clinical events will be collected prospectively and adjudicated by an independent Clinical Events Committee blinded to treatment allocation. Patient safety and trial conduct will be monitored by an independent Data Safety Monitoring Board. After hospital discharge, participants will undergo structured clinical follow-up to assess clinical status, adverse events, hospitalizations, and other relevant outcomes. The overall aim of TRACS-PRIME is to determine whether a carefully controlled strategy of TAVI in selected centers without on-site cardiac surgery can preserve patient safety while potentially improving access to timely treatment for patients with severe aortic stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two parallel treatment groups. In the experimental group, TAVI is performed in a center without on-site cardiac surgery. In the control group, TAVI is performed in a center with on-site cardiac surgery. Patients in both groups are managed according to current standards of care and followed prospectively for clinical and safety outcomes.
| Arm | Type | Receives |
|---|---|---|
| TAVI in center without on-site cardiac surgery | Experimental | Procedure: Transcatheter Aortic Valve ImplantationParticipants assigned to this arm will undergo transcatheter aortic valve implantation in a participating center without on-site cardiac surgery. The procedure will be performed by experienced TAVI operators according to current guidelines, institutional standards, and pre-procedural Heart Team assessment. Participating centers must have appropriate imaging, procedural expertise, and predefined pathways for rapid transfer to a referral cardiac surgery center if needed. |
| TAVI in center with on-site cardiac surgery | Active comparator | Procedure: Transcatheter Aortic Valve ImplantationParticipants assigned to this arm will undergo transcatheter aortic valve implantation in a center with on-site cardiac surgery. After randomization, patients will be referred to the collaborating cardiac surgery center and treated according to the local waiting list and standard clinical practice. The procedure will be performed by experienced TAVI operators in accordance with current guidelines, institutional standards, and pre-procedural Heart Team assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Severe aortic stenosis
- Indication to TAVI confirmed by the Heart Team
- Prohibitive operative risk
- High surgical risk as defined as STS score >8%
- Porcelain aorta or severely atherosclerotic aorta
Key exclusion criteria (5 listed)
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Non-cardiovascular comorbidity reducing life expectancy to <1 year
- Any factor precluding 1-year follow-up
- Refusal of informed consent
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationTranscatheter aortic valve implantation is performed as the study procedure in patients with severe aortic stenosis and an indication for TAVI confirmed by the multidisciplinary Heart Team. The procedure is performed according to current guidelines and institutional standards by experienced TAVI operators. In this trial, the intervention is evaluated according to the setting in which it is performed: either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. | Procedure or surgery | TAVI in center with on-site cardiac surgery, TAVI in center without on-site cardiac surgery |
Primary outcome
all-cause mortality, all stroke, or hospitalization for procedure- or valve-related causes
Time frame: 1-year
The primary clinical efficacy outcome is a composite endpoint defined as the occurrence of any of the following events within 1 year after randomization: death from any cause, any stroke, or hospitalization related to the TAVI procedure or to the implanted valve. This endpoint will be assessed prospectively and adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
10 secondary outcomes
All-cause death
Time frame: 1-year
Cardiovascular death
Time frame: 1-year
All stroke
Time frame: 1-year
Ischemic stroke
Time frame: 1-year
Haemorrhagic stroke
Time frame: 1-year
Stroke not otherwise specified
Time frame: 1-year
Procedure-related or valve-related hospitalization
Time frame: 1-year
Other cardiovascular hospitalization
Time frame: 1-year
Myocardial infarction
Time frame: 1-year
Aortic bioprosthetic valve dysfunction
Time frame: 1-year
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 Aug 2026.
- Background: PubMed 39505122Iannopollo G, Cocco M, Leone A, Sacca S, Mangino D, Picchi A, Reccia MR, Fineschi M, Meliga E, Audo A, Nobile G, Tumscitz C, Penzo C, Saia F, Rubboli A, Moretti C, Vignali L, Niccoli G, Cimaglia P, Rognoni A, Aschieri D, Iaccarino D, Ottani F, Cavazza C, Varbella F, Secco GG, Bolognese L, Limbruno U, Guiducci V, Campo G, Casella G. Transcatheter aortic-valve implantation with or without on-site cardiac surgery: The TRACS trial. Am Heart J. 2025 Feb;280:7-17. doi: 10.1016/j.ahj.2024.10.019. Epub 2024 Nov 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data may be made available upon reasonable request after publication of the main study results. Requests will be reviewed by the Steering Committee and will be considered based on scientific merit, feasibility, participant privacy, and compliance with applicable ethical and regulatory requirements. Any data sharing will require appropriate approvals and a data use agreement.
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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.
Gianluca Campo, MD principal investigator
University Hospital of Ferrara
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation in people with Aortic Stenosis, run by University Hospital of Ferrara at 11 sites in Italy.
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 12 inclusion and 5 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. 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 Gianluca Campo, MD (0532236450 ext. +39, cmpglc@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality, all stroke, or hospitalization for procedure- or valve-related causes (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604402, which also lists 1 linked publication.
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 Aug 2026.