TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery

Summary

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.

Eligibility

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

Conditions2

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