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TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery (TRACS-PRIME)

19 augusti 2026 uppdaterad av: Gianluca Campo, University Hospital of Ferrara

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

1612

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Gianluca Campo, MD
  • Telefonnummer: +39 0532236450
  • E-post: cmpglc@unife.it

Studera Kontakt Backup

Studieorter

  • Italien
      • Andria, Italien
        • Rekrytering
        • Ospedale "L. Bonomo" - Andria - ASL Barletta Andria Trani
        • Kontakt:
      • Arezzo, Italien
      • Bologna, Italien
        • Rekrytering
        • Ospedale Maggiore CA Pizzardi, AUSL di Bologna
        • Kontakt:
      • Ferrara, Italien
        • Har inte rekryterat ännu
        • Azienda Ospedaliero Universitaria di Ferrara
        • Kontakt:
      • Grosseto, Italien
        • Rekrytering
        • Ospedale Misericordia di Grosseto
        • Kontakt:
      • L’Aquila, Italien
        • Rekrytering
        • Ospedale Regionale San Salvatore
        • Kontakt:
      • Mirano, Italien
      • Ravenna, Italien
        • Rekrytering
        • Ospedale Santa Maria delle Croci, AUSL Romagna
        • Kontakt:
      • Rimini, Italien
        • Rekrytering
        • Ospedale degli Infermi di Rimini
        • Kontakt:
      • Venezia, Italien
      • Verona, Italien
        • Rekrytering
        • Ospedale Sacro Cuore Don Calabria, Negrar
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion criteria

  1. Severe aortic stenosis
  2. Indication to TAVI confirmed by the Heart Team

AND one of the following enrichment criteria:

  1. Prohibitive operative risk
  2. High surgical risk as defined as STS score >8%
  3. Porcelain aorta or severely atherosclerotic aorta
  4. Frailty/Reduced physical performance
  5. Severe liver disease/cirrhosis
  6. Hostile chest and/or internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
  7. Severe pulmonary hypertension and/or severe right ventricular dysfunction
  8. Age ≥85 years
  9. 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.

Exclusion criteria

  1. Unsuitable for transfemoral TAVI
  2. Emergent TAVI
  3. Non-cardiovascular comorbidity reducing life expectancy to <1 year
  4. Any factor precluding 1-year follow-up
  5. Refusal of informed consent

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: TAVI in center without on-site cardiac surgery
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.
Procedur: Transcatheter Aortic Valve Implantation
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.
Aktiv komparator: TAVI in center with on-site cardiac surgery
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.
Procedur: Transcatheter Aortic Valve Implantation
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
all-cause mortality, all stroke, or hospitalization for procedure- or valve-related causes
Tidsram: 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.
1-year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Död av alla orsaker
Tidsram: 1 år
1 år
Cardiovascular death
Tidsram: 1-year
1-year
All stroke
Tidsram: 1-year
1-year
Ischemic stroke
Tidsram: 1-year
1-year
Haemorrhagic stroke
Tidsram: 1-year
1-year
Stroke not otherwise specified
Tidsram: 1-year
1-year
Procedure-related or valve-related hospitalization
Tidsram: 1-year
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.
1-year
Other cardiovascular hospitalization
Tidsram: 1-year
1-year
Myocardial infarction
Tidsram: 1-year
1-year
Aortic bioprosthetic valve dysfunction
Tidsram: 1-year
1-year

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Valve-related mortality, cardiac structural complications or other acute procedural and technical valve-related complications
Tidsram: 1-year
The primary safety outcome is a composite endpoint defined as the occurrence within 1 year of any of the following events: valve-related mortality, cardiac structural complications, or other acute procedural and technical valve-related complications. Events will be defined according to VARC-3 criteria and adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
1-year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital of Ferrara

Samarbetspartners

Consorzio Futuro in Ricerca

Utredare

  • Huvudutredare: Gianluca Campo, MD, University Hospital Of Ferrara

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 maj 2026

Primärt slutförande (Beräknad)

25 maj 2030

Avslutad studie (Beräknad)

25 maj 2034

Studieregistreringsdatum

Först inskickad

17 maj 2026

Först inskickad som uppfyllde QC-kriterierna

17 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 635/2025/Sper/AOUFe

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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