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

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: Recruiting
• Conditions: Aortic Stenosis, Severe
• Intervention / Treatment: Procedure: TAVI WITH ON-SITE SURGERY; Procedure: TAVI WITHOUT ON-SITE SURGERY

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 (Estimated): 566
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianmarco Iannopollo, Md; Phone Number: 0513138704; Email: gianmarco.iannopollo@ausl.bologna.it

Study Locations

• Italy
  • Arezzo, Italy
    • Recruiting
    • Ospedale San Donato di Arezzo
    • Contact: Leonardo Bolognese
  • Asti, Italy
    • Recruiting
    • Ospedale Cardinal Massaia Di Asti
  • Biella, Italy
    • Recruiting
    • Ospedale degli Infermi di Biella
  • Bologna, Italy, 40100
    • Recruiting
    • Azienda Unita Sanitaria Locale
    • Contact: Gianmarco Iannopollo, Md; Phone Number: 0513138704; Email: gianmarco.iannopollo@ausl.bologna.it
    • Sub-Investigator: Gianni Casella, Md
    • Principal Investigator: Gianmarco Iannopollo, Md
  • Ferrara, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria di Ferrara
    • Contact: Carlo Tumscitz
  • Grosseto, Italy
    • Recruiting
    • Ospedale Misericordia di Grosseto
  • Mirano, Italy
    • Recruiting
    • Azienda ULSS 3 Serenissima, Ospedale di Mirano
    • Contact: Salvatore Saccà
  • Piacenza, Italy
    • Recruiting
    • Ospedale Guglielmo da Saliceto di Piacenza
  • Reggio Emilia, Italy
    • Recruiting
    • Azienda Ospedaliera di Reggio Emilia

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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

• Sponsor: Azienda Usl di Bologna
• Collaborators: Università degli Studi di Ferrara; University Hospital of Ferrara; Azienda Unità Sanitaria Locale Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2028

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, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• 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