CompletedNot Applicable

TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3

France250 participantsStarted 2016-06-08

Plain-language summary

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptomatic Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2) * Males or females of at least 18 years of age * Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team * Signed informed consent * TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience) Exclusion Criteria: * Transapical TAVI * Preexisting aortic prosthesis (valve in valve technique) * Vascular conditions that make insertion and endovascular access to the aortic valve impossible * BAV performed for less than one week * Recent myocardial infarction (STEMI within the last 3 months) * Left ventricular or atrial thrombus by echocardiography * Mitral or tricuspidal valvular insufficiency (\> grade II) * Evolutive or recent cerebrovascular event (within the last 3 months) * Symptomatic carotid or vertebral arterial narrowing (\>70%) disease * Bleeding diathesis or coagulopathy or patient refusing blood transfusion * Lack of written informed consent, severe mental disorder, drug/alcohol addiction * Life expectancy \< 1 year * Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media that cannot be adequately premedicated * Participation in another drug or device study that would jeopardize the appropriate…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested whether TAVI could be done without balloon predilatation using the SAPIEN 3 valve — since the trial is now completed, can you tell me what the results showed about immediate procedural success, and what that might mean for how my procedure could be approached?
2Since this study specifically looked at skipping the balloon-stretching step before valve implantation, what are the potential risks and benefits of that approach compared to the traditional method that includes predilatation, and which approach would you use for me?
3This trial didn't have a formal phase designation, which suggests it may have been more of a procedural technique study — does that affect how confident you are in applying its findings to my specific situation?
4Given that this trial focused on immediate procedural success as its main outcome, do we have any longer-term data on how patients who had TAVI without predilatation fared over months or years, and should that uncertainty factor into my decision?
5Before considering whether this trial's approach might apply to my care, are there standard treatment options or other studies I should weigh first given my current severity of aortic valve stenosis?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

immediate procedural success

Timeframe: up to 72h

Trial details

NCT IDNCT02729519

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-29

View on ClinicalTrials.gov More Aortic Valve Stenosis trials