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

Azienda Usl di Bologna

Status: Enrolling

Conditions: Aortic Stenosis, Severe

Treatments: Procedure: TAVI WITHOUT ON-SITE SURGERY; Procedure: TAVI WITH ON-SITE SURGERY

Study type: Interventional

Funder types: Other

Identifiers

NCT05751577

40-2023-SPER-AUSLBO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 566 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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566 participants in 2 patient groups

EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY

Experimental group

Description:

After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery

Treatment:

Procedure: TAVI WITHOUT ON-SITE SURGERY

CONTROL ARM: TAVI WITH ON-SITE SURGERY

Active Comparator group

Description:

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

Treatment:

Procedure: TAVI WITH ON-SITE SURGERY