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New treatment option for Aortic Valve Stenosis
Official title Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
ClinicalTrials.gov ID: NCT03728049
What this study is testing
- What it's testing
- Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the will be eligible for entry in the study...
- Symptomatic aortic stenosis scheduled to undergo TAVI
- TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
- All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted
You likely can't join if
- TAVI through non-transfemoral approach
- TAVI with concomitant percutaneous coronary intervention
- TAVI performed under general anesthesia
- TAVI performed under TEE guidance
- Valve-in-valve procedure
- Inability to provide informed consent
See the full eligibility criteria
- All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.
- Symptomatic aortic stenosis scheduled to undergo TAVI
- TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
- All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted
- TAVI through non-transfemoral approach
- TAVI with concomitant percutaneous coronary intervention
- TAVI performed under general anesthesia
- TAVI performed under TEE guidance
- Valve-in-valve procedure
- Inability to provide informed consent
- Associated ≥ moderate mitral regurgitation
- Peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Lille, France
- Montpellier, France
- Nîmes, France
- Paris, France
- Pessac, France
- Rennes, France
- Strasbourg, France
- Toulouse, France
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Lille, France; Montpellier, France; Nîmes, France; Paris, France; Pessac, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.