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New treatment option for Severe Aortic Valve Stenosis
Official title In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
ClinicalTrials.gov ID: NCT06859255
What this study is testing
- What it's testing
- The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques. The study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardiac MRI (magnetic resonance imaging) without contrast medium, to be performed between 1 and 3 months after the operation.
- Time commitment: about 24 months
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
- patients who underwent SAVR or TAVI for severe aortic stenosis
- implanted with valve models and sizes among those which we evaluated in vitro
You likely can't join if
- treated or untreated aortic root/ascending aorta aneurysm
- preoperative aortic regurgitation more than moderate
- recent (\<12 weeks)/ concomitant revascularization
- recent (\<12 weeks) ACS
- PPI (permanent pacemaker implantation)
- other than sinus rythm
See the full eligibility criteria
- patients who underwent SAVR or TAVI for severe aortic stenosis
- implanted with valve models and sizes among those which we evaluated in vitro
- treated or untreated aortic root/ascending aorta aneurysm
- preoperative aortic regurgitation more than moderate
- recent (\<12 weeks)/ concomitant revascularization
- recent (\<12 weeks) ACS
- PPI (permanent pacemaker implantation)
- other than sinus rythm
- Paravalvular leak (PVL) \> moderate.
The study team makes the final eligibility decision.
Where it's taking place
- Bari, Apulia, Italy
- San Donato, Lombardy, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Bari, Apulia, Italy; San Donato, Lombardy, Italy. 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.