BridgeMD
New treatment option for Severe Aortic Stenosis
Official title Transfemoral TAVI With or Without Coronary Angiogram in Patients With Severe Aortic Stenosis (PURE TAVI)
ClinicalTrials.gov ID: NCT06898086
What this study is testing
- What it's testing
- This study will be conducted in patients with severe aortic stenosis who are referred for transcatheter aortic valve implantation (TAVI). TAVI is the recommended treatment for severe aortic stenosis.
- 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
Ages 18 to 120
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Klagenfurt, Austria
- Prague, Czechia
- Nice, France
- Toulouse, France
- Düsseldorf, North Rhine-Westphalia, Germany
- Essen, Germany
- Freiburg im Breisgau, Germany
- Lübeck, Germany
- Ulm, Germany
- Palermo, Basel-Stadt, Italy
- Pisa, Basel-Stadt, Italy
- Catania, Italy
- Mestre, Italy
- Roma, Italy
- Siena, Italy
- Trieste, Italy
- Amsterdam, Netherlands
- Maastricht, Netherlands
- Basel, Canton of Basel-City, Switzerland
+ 1 more site(s).
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, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Klagenfurt, Austria; Prague, Czechia; Nice, France; Toulouse, France; Düsseldorf, North Rhine-Westphalia, Germany and 15 more location(s). 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.