Treatment of severe aortic stenosis (narrowing of the left heart valve through which blood flows from the heart to the rest of the body) with transfemoral TAVI (transcatheter aortic valve implantation) with or without coronary angiography (a special procedure in which dynamic X-rays of the heart are taken) during diagnostic evaluation.
Summary description of the study
This study focuses on patients with severe aortic stenosis, a condition where the left heart valve (aortic valve) is narrowed. As a result, the heart has to work harder to pump blood, and/or blood flow to the rest of the body may be significantly restricted, leading to symptoms such as shortness of breath, chest pain, and dizziness. The recommended treatment for aortic stenosis is transcatheter aortic valve implantation (TAVI), a minimally invasive procedure in which a new valve is inserted into the old, narrowed valve. Before TAVI, a coronary angiogram is typically performed to check if the blood vessels supplying blood to the heart (coronary arteries) are blocked and to determine the correct valve size. If blockages are found, they are treated before or during the TAVI. The aim of this study is to investigate whether forgoing a coronary angiography prior to TAVI is as safe and effective as the standard method. Since this is a randomized study, the randomization process determines which of the two study groups the patient will belong to. This randomization process is comparable to flipping a coin and means that patients, after giving their consent, are randomly assigned to either the control or experimental group. The patient has a 50% chance of being assigned to one of the two groups. Both groups will use the CE-certified Myval transcatheter heart valve, which provides a precise fit and optimal performance. After TAVI, patients will be invited for follow-up examinations at 6, 12, and 24 months, where they will complete questionnaires on quality of life (EQ-5D-5L, KCCQ) and neurological performance (NIHSS, mRS). Their current medication and adverse events will also be documented.
(BASEC)
Intervention under investigation
to investigate whether a TAVI method without prior coronary angiography is not inferior to a conventional TAVI method, where a routine coronary angiography is performed with or without revascularization, in patients with significant aortic stenosis who do not have typical angina pectoris classified as CCS 3 or higher.
Patients will be randomly assigned to two study groups. Patients assigned to the first group, the experimental strategy group, will not undergo invasive coronary angiography during the routine diagnostic examination prior to TAVI, so the coronary status before TAVI will be unknown. In contrast, patients randomized to group two, the control strategy (standard of care), will undergo a routine diagnostic examination including invasive coronary angiography before TAVI. The percutaneous coronary intervention will be performed according to the standard of care principle.
(BASEC)
Disease under investigation
Patients with severe aortic stenosis who are candidates for transcatheter aortic valve implantation.
(BASEC)
- The patient is over 18 years old and has severe AS considered for TAVI by a multidisciplinary heart team. - The patient is a candidate for transfemoral TAVI according to local standards and current guidelines. - The patient is willing and able to provide written consent to participate in the study and confirms that they are able to attend the expected follow-up examinations. (BASEC)
Exclusion criteria
- The patient has had a coronary angiogram within the last 5 years with or without PCI and/or CABG or CCTA. - Left main PCI in the medical history - The patient has CCS angina of 3 or more. - The patient has a left ventricular ejection fraction <30%. - Patients for whom TAVI via the femoral access is not possible due to clinical assessment or history ad priori - Patients treated for an acute myocardial infarction within 30 days prior to randomization. - The patient has a planned open-heart surgery. - Pregnant patient at the time of enrollment and female patient of childbearing age. - The patient has a life expectancy of less than 1 year due to another severe non-cardiac condition. - The patient is participating in another clinical study with an investigational product, whose follow-up period has not yet been completed. - The patient has received prior treatment for aortic valve implantation or aortic valve replacement. (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Rede Optimus Hospitalar AG
(BASEC)
Contact
Contact Person Switzerland
Mr. Gavin Vaz
+4917615203939
gavin.vaz@clutterredeoptimus.comRede Optimus Hospitalar AG
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
13.06.2025
(BASEC)
ICTRP Trial ID
NCT06898086 (ICTRP)
Official title (approved by ethics committee)
Treatment of severe aortic stenosis with transfemoral TAVI with or without coronary angiogram during diagnostic work-up (PURE TAVI) (BASEC)
Academic title
Treatment of Severe Aortic Stenosis With Transfemoral TAVI With or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI) (ICTRP)
Public title
Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI) (ICTRP)
Disease under investigation
Severe Aortic Stenosis (ICTRP)
Intervention under investigation
Device: Transcatheter aortic valve implantation (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Patient is older than 18 years with severe AS considered for TAVI by a
multidisciplinary heart team.
- Patient is candidate for transfemoral TAVI as per local standards and current
guidelines.
- Patient is willing and capable to give written consent to participate to the trial
and confirmed to be able to attend the expected follow up visits.
Exclusion Criteria:
- Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG
within last 5 years.
- Left main PCI in the medical history
- Patient has CCS of 3 or more.
- Patient has left ventricular ejection fraction <30%.
- Patients in whom TAVI through femoral access is ad priori not possible based on
clinical assessment or medical history
- Patient has been treated for acute myocardial infarction within 30 days before
randomization.
- Patient has a planned open-heart surgery.
- Patient has a life expectancy less than 1 year due to other severe non-cardiac
disease.
- Patient is participating in another clinical study with an investigational product
that has not yet completed the follow up period.
- Patient has received previous treatment for aortic valve implantation or
replacement.
- Female patient who is pregnant at the time of inclusion and female patient of
childbearing potential (ICTRP)
not available
Primary and secondary end points
Composite of all-cause death, spontaneous or periprocedural myocardial infarction, etc (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Dr. William Wijns, ProfessorDr. Gabor G Toth, ProfessorDr. Felix Mahfoud, ProfessorFlavio Ribichini, ProfessorDr. Emanuele Barbato, ProfessorDr. Peter Jni, ProfessorJulie Bosiers, julie.bosiers@redeoptimus.com, +32 479 64 37 60 (ICTRP)
Secondary trial IDs
RO-240905 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06898086 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available