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New treatment option for Aortic Stenosis
Official title TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery
ClinicalTrials.gov ID: NCT07604402
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Severe aortic stenosis
- Indication to TAVI confirmed by the Heart Team AND one of the following enrichment criteria:
- Prohibitive operative risk
- High surgical risk as defined as STS score \>8%
- Porcelain aorta or severely atherosclerotic aorta
You likely can't join if
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Non-cardiovascular comorbidity reducing life expectancy to \<1 year
- Any factor precluding 1-year follow-up
- Refusal of informed consent
See the full eligibility criteria
- Severe aortic stenosis
- Indication to TAVI confirmed by the Heart Team AND one of the following enrichment criteria:
- Prohibitive operative risk
- High surgical risk as defined as STS score \>8%
- Porcelain aorta or severely atherosclerotic aorta
- Frailty/Reduced physical performance
- Severe liver disease/cirrhosis
- Hostile chest and/or 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
- Age ≥85 years
- 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...
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Non-cardiovascular comorbidity reducing life expectancy to \<1 year
- Any factor precluding 1-year follow-up
- Refusal of informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Ferrara, Italy
- Mirano, Italy
- Venezia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ferrara, Italy; Mirano, Italy; Venezia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.