Aortic Stenosis, SevereTRACSNCT05751577
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
A study testing TAVI WITHOUT ON-SITE SURGERY and TAVI WITH ON-SITE SURGERY in people with Aortic Stenosis, Severe, run by Azienda Usl di Bologna at 14 sites in Italy.
Trial summary
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- TAVI WITHOUT ON-SITE SURGERY and TAVI WITH ON-SITE SURGERY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 14 sitesItaly
- Study dates
- 1 May 2023to 31 Mar 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis
- Indication to TAVI confirmed by the Study Heart Team
- AND one of the following:
- Inoperable due to prohibitive operative risk
- High surgical risk as defined as STS score >8%
- The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
Show all 15Show fewer
- Porcelain aorta or severely atherosclerotic aorta
- Frailty/Reduced physical performance
- Cognitive impairment, dementia, or Parkinson's disease
- Severe liver disease/cirrhosis
- Hostile chest
- 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
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Age ≥85 years
Who cannot join
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Noncardiovascular comorbidity reducing life expectancy to <1 year
- Any factor precluding 1-year follow-up
- Refusal informed consent
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Ospedale San Donato di Arezzo
Arezzo
Ospedale Cardinal Massaia di Asti
Asti
Ospedale degli Infermi di Biella
Biella
Azienda Unità Sanitaria Locale
Bologna, Bologna, 40100
Azienda Ospedaliero Universitaria di Ferrara
Ferrara
Ospedale "Morgagni - Pierantoni" di Forlì
Forlì
Ospedale Misericordia di Grosseto
Grosseto
Azienda ULSS 3 Serenissima, Ospedale di Mirano
Mirano
Ospedale Civile di Baggiovara
Modena
Ospedale Guglielmo da Saliceto di Piacenza
Piacenza
Ospedale Santa Maria delle Croci
Ravenna
Azienda Ospedaliera di Reggio Emilia
Reggio Emilia
Ospedale Infermi di Rimini
Rimini
Ospedale Civile di Venezia SS Giovanni e Paolo
Venezia
About this study
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.
Read the detailed description
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE). The TRACS trial will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery. Thus, participating centers and their study TAVI operators must follow selective criteria for eligibility. Participants will be recruited after Heart Team indication to TAVI procedure. The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team. Study patients will be randomized in a 2:1 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery.
- Conditions
- Aortic Stenosis, Severe
- Being tested
- TAVI WITHOUT ON-SITE SURGERY, TAVI WITH ON-SITE 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.
TAVI WITHOUT ON-SITE SURGERYProcedure or surgery
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery
TAVI WITH ON-SITE SURGERYProcedure or surgery
After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY | Experimental | After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery Receives: Procedure: TAVI WITHOUT ON-SITE SURGERY |
| CONTROL ARM: TAVI WITH ON-SITE SURGERY | Active comparator | After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter Receives: Procedure: TAVI WITH ON-SITE SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint
1-year cumulative occurrence of all-cause death, stroke and hospital readmission for CV cause To test if the outcome of TAVI procedures performed by experienced operators in the center without onsite cardiac surgery is non inferior to that of TAVI procedures performed by the same team in the center with on-site cardiac surgery
Measured: 1-year
Primary safety endpoint
To test whether mortality due to periprocedural complications actionable by emergent cardiac surgery differs between the TAVI procedures performed in the center without on-site cardiac surgery and the TAVI procedures performed by the same team in the center with on-site cardiac surgery
Measured: 1-year
Secondary outcomes (2)
Secondary efficacy endpoints
All-cause death Cardiovascular death Myocardial infarction Hospital admission for cardiovascular cause Hospital admission for heart failure Cerebrovascular accident Ischemic stroke Hospital admission for pneumonia (± respiratory failure) Need for balloon aortic valvuloplasty for emergent condition Quality of life measured with the Eq-5D and KCCQ-12 scales Time spent on the waiting list before TAVI
Measured: 1-year
Other safety endpoints
Cardiac tamponade Bleeding Kidney failure (requirement for renal replacement therapy) Severe aortic regurgitation (aortic regurgitation according to current guidelines) Multiorgan failure (failure of at least two organ systems) Vascular access site and access related complications Conduction disturbances and arrhythmias Endocarditis Valve thrombosis Valve malpositioning Valve embolization Ectopic valve deployment TAV-in-TAV deployment
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 posted2 Mar 2023
- Study start1 May 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (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 Stenosis, SevereStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, University Hospital of Ferrara
- Responsible party
- Sponsor
- Investigators
- Gianmarco Iannopollo, MD, Principal investigator, Azienda Unità Sanitaria Locale Bologna, Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751577
- Sponsor's protocol ID
- 40-2023-SPER-AUSLBO
- Acronym
- TRACS
- Status last verified
- Apr 2026
- First submitted
- 21 Feb 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
- ClinicalTrials.gov ID
- NCT05751577
- Acronym / sponsor ID
- TRACS / 40-2023-SPER-AUSLBO
- Conditions
- Aortic Stenosis, Severe
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 657 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, University Hospital of Ferrara
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 2 Mar 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.
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.
Detailed description
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE). The TRACS trial will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery. Thus, participating centers and their study TAVI operators must follow selective criteria for eligibility. Participants will be recruited after Heart Team indication to TAVI procedure. The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team. Study patients will be randomized in a 2:1 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY | Experimental | Procedure: TAVI WITHOUT ON-SITE SURGERYAfter randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery |
| CONTROL ARM: TAVI WITH ON-SITE SURGERY | Active comparator | Procedure: TAVI WITH ON-SITE SURGERYAfter randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Severe aortic stenosis
- Indication to TAVI confirmed by the Study Heart Team
- Inoperable due to prohibitive operative risk
- High surgical risk as defined as STS score >8%
- The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
Key exclusion criteria (5 listed)
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Noncardiovascular comorbidity reducing life expectancy to <1 year
- Any factor precluding 1-year follow-up
- Refusal 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 |
|---|---|---|
| TAVI WITHOUT ON-SITE SURGERYAfter randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery | Procedure or surgery | EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY |
| TAVI WITH ON-SITE SURGERYAfter randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter | Procedure or surgery | CONTROL ARM: TAVI WITH ON-SITE SURGERY |
Primary outcome
Primary efficacy endpoint
Time frame: 1-year
1-year cumulative occurrence of all-cause death, stroke and hospital readmission for CV cause To test if the outcome of TAVI procedures performed by experienced operators in the center without onsite cardiac surgery is non inferior to that of TAVI procedures performed by the same team in the center with on-site cardiac surgery
Primary safety endpoint
Time frame: 1-year
To test whether mortality due to periprocedural complications actionable by emergent cardiac surgery differs between the TAVI procedures performed in the center without on-site cardiac surgery and the TAVI procedures performed by the same team in the center with on-site cardiac surgery
2 secondary outcomes
Secondary efficacy endpoints
Time frame: 1-year
Other safety endpoints
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 8 Apr 2026.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis, Severe
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruiting
Effect of Double-Tap Optimization on Valve Expansion and Hemodynamics in Balloon-expandable Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial (DO-OPT TAVI Trial)
Severe Aortic Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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. This study is not recruiting at the moment.
Gianmarco Iannopollo, MD principal investigator
Azienda Unità Sanitaria Locale Bologna, Bologna
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI WITHOUT ON-SITE SURGERY and TAVI WITH ON-SITE SURGERY in people with Aortic Stenosis, Severe, run by Azienda Usl di Bologna at 14 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 15 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint (time frame: 1-year). The study lists 2 primary outcomes in all. 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 NCT05751577, 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 8 Apr 2026.