TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial (TRACS)

April 3, 2026 updated by: Azienda Usl di Bologna
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

657

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Arezzo, Italy
        • Ospedale San Donato di Arezzo
      • Asti, Italy
        • Ospedale Cardinal Massaia di Asti
      • Biella, Italy
        • Ospedale degli Infermi di Biella
      • Ferrara, Italy
        • Azienda Ospedaliero Universitaria di Ferrara
      • Forlì, Italy
        • Ospedale "Morgagni - Pierantoni" di Forlì
      • Grosseto, Italy
        • Ospedale Misericordia di Grosseto
      • Mirano, Italy
        • Azienda ULSS 3 Serenissima, Ospedale di Mirano
      • Modena, Italy
        • Ospedale Civile di Baggiovara
      • Piacenza, Italy
        • Ospedale Guglielmo da Saliceto di Piacenza
      • Ravenna, Italy
        • Ospedale Santa Maria delle Croci
      • Reggio Emilia, Italy
        • Azienda Ospedaliera di Reggio Emilia
      • Rimini, Italy
        • Ospedale Infermi di Rimini
      • Venezia, Italy
        • Ospedale Civile di Venezia SS Giovanni e Paolo
    • Bologna
      • Bologna, Bologna, Italy, 40100
        • Azienda Unità Sanitaria Locale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

  • 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

Exclusion Criteria:

  • Unsuitable for transfemoral TAVI
  • Emergent TAVI
  • Noncardiovascular comorbidity reducing life expectancy to <1 year
  • Any factor precluding 1-year follow-up
  • Refusal informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CONTROL ARM: TAVI WITH ON-SITE 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
Procedure: TAVI WITH ON-SITE 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
Experimental: EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery
Procedure: TAVI WITHOUT ON-SITE SURGERY
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-year
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
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy endpoints
Time Frame: 1-year
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
1-year
Other safety endpoints
Time Frame: 1-year
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
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Collaborators

University Hospital of Ferrara
Azienda USL Reggio Emilia - IRCCS

Investigators

  • Principal Investigator: Gianmarco Iannopollo, MD, Azienda Unità Sanitaria Locale Bologna, Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40-2023-SPER-AUSLBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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