TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery
TRACS-PRIME
1 other identifier
interventional
1,612
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
May 25, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2030
Study Completion
Last participant's last visit for all outcomes
May 30, 2034
May 22, 2026
May 1, 2026
4 years
May 17, 2026
May 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1-year
Secondary Outcomes (10)
All-cause death
1-year
Cardiovascular death
1-year
All stroke
1-year
Ischemic stroke
1-year
Haemorrhagic stroke
1-year
- +5 more secondary outcomes
Other Outcomes (1)
Valve-related mortality, cardiac structural complications or other acute procedural and technical valve-related complications
1-year
Study Arms (2)
TAVI in center without on-site cardiac surgery
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of Ferraralead
- Consorzio Futuro in Ricercacollaborator
Related Publications (1)
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.
PMID: 39505122BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gianluca Campo, MD
University Hospital of Ferrara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The trial is open-label because the treatment setting cannot be concealed from participants, care providers, or investigators. Clinical outcomes are assessed by an independent Clinical Events Committee whose members are blinded to treatment allocation, participating center, and patient identifiers. Adjudication is performed according to predefined endpoint definitions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Cardiology
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start (Estimated)
May 25, 2026
Primary Completion (Estimated)
May 30, 2030
Study Completion (Estimated)
May 30, 2034
Last Updated
May 22, 2026
Record last verified: 2026-05