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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Stenosis, Severe

Intervention / Treatment
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* Procedure: TAVI WITHOUT ON-SITE SURGERY
* Procedure: TAVI WITH ON-SITE SURGERY


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY<br>After randomization, study TAVI operators of the participating center will schedule the patient for TAVI within 7-10 days in their hospital without on-site surgery | Procedure: TAVI WITHOUT ON-SITE SURGERY<br>* After randomization, study TAVI operators of the participating center will schedule the patient for TAVI within 7-10 days in their hospital without on-site surgery<br>|
| Active Comparator: CONTROL ARM: TAVI WITH ON-SITE SURGERY<br>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<br>* 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<br>|

What is the study measuring?
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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 |