University hopsital
Montpellier, Occitanie, 34295, France
Location status: Recruiting
Location contact
FLORENCE LECLERCQ, MD, PhD
CONTACT
FLORENCE LECLERCQ, MD, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07506382
We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)
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Request Info18 year and older
All sexes
Observational
Montpellier, Occitanie, 34295, France
Location status: Recruiting
FLORENCE LECLERCQ, MD, PhD
CONTACT
FLORENCE LECLERCQ, MD, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
Compared with balloon-expandable valves, self-expandable supra annular devices (Mertronic Evolut) offer superior post-procedural hemodynamics in TAVR and are, therefore, expected to play a growing role in clinical practice particularly in small aortic anatomies . However, the relatively long stent frame of self-expandable valves posed challenges for coronary access after implantation and PPI rates remain higher, despite lower implantation height with the cusp overlap technique The Navitor valves (Abbott Structural Valve) is a new generation intra-annular self-expandable device with tall stent frame but larger stent cells and shorter outer skirt which may be more favorable for future coronary access than the Evolut FX valves, particularly in patients with lower coronary heights . The Navitor platform showed satisfying data in tricuspid anatomy, providing intra-annular leaflets, an innovative sealing cuff, and repositionability .However this platform showed a high rate of PPI that could be related to the need for lower implantation to stabilize the device (first generation) Considering the lack of specific data regarding the compared performance of the 2 plateforms including latest generation devices, we aimed to evaluate procedural success, clinical and hemodynamic results, and conductive disorders between the 2 platforms in an observational real life study
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
Time frame: 1 month follow up
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Acronym: NEOVALVE
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