NCT07885761Toborzás még nem indult
REVIVE-FR Registry
REVIVE-FR: A French Multicenter, Prospective and Retrospective, Observational Registry of TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation, and Medical Management for Failed Aortic Bioprostheses
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 21.
Rövid összefoglaló (regiszter, angolul)
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly. As patients with severe aortic stenosis are increasingly younger and at lower surgical risk, more patients may experience bioprosthetic valve failure during their lifetime. Treatment options include implanting a new valve inside the existing valve using a catheter-based procedure, surgically removing the failed valve, or providing conservative medical treatment. The study will evaluate outcomes associated with these different treatment strategies to improve understanding of their benefits and risks and help guide future treatment decisions for patients with bioprosthetic valve failure.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 200 (tervezett)
- Első benyújtás
- 2026. okt. 13.
- Kezdés
- 2027. márc. 15.
- Elsődleges befejezés
- 2029. ápr. 15.
- Fő szponzor
- Institut für Pharmakologie und Präventive Medizin
- NCT-szám
- NCT07885761
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 200
- 2027. márc. 15. és az elsődleges befejezés (2029. ápr. 15.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior mechanical aortic valve prosthesis.
- Anticipated need for a concomitant cardiac surgical procedure favoring surgical explantation over a transcatheter approach.
- Concurrent or planned TAVI-in-SAVR, THV-in-THV, or surgical explantation for the same THV failure episode.
Más betegség
- Active malignancy or ongoing chemotherapy; life expectancy below 12 months
- Malignancy or ongoing chemotherapy; life expectancy below 12 months.
Egyéb
- Planned non-transfemoral access (e.g., transapical, transaortic, transcaval, subclavian/axillary).
- Emergency/salvage (non-elective) procedure.
- Presence of LV thrombus.
- Lack of informed consent.
- Lack of informed consent or non-opposition.
Kiket keres a vizsgálat
- Men and women, ≥ 18 years, with a documented indication for transcatheter or surgical reintervention] on a failed aortic bioprosthesis, or a documented diagnosis of failing THV managed medically, in one of the following four categories:
- Failed surgical bioprosthetic valve (any brand/model), with SVD or other bioprosthetic valve dysfunction, indicated for TAVI-in-SAVR; planned new valve SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA; planned and anatomically suitable transfemoral access.
- Failed THV (any brand), with Stage II or III SVD according to VARC-3, indicated for THV-in-THV; planned new valve SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA; planned and anatomically suitable transfemoral access.
- Failed THV (any brand), any VARC-3 failure mechanism, indicated for surgical explantation (Explant-TAVR cohort) per Heart Team decision.
- Failing THV (any brand), due to Stage II or III SVD per VARC-3 or due to infective endocarditis, managed medically - i.e., without TAVI-in-SAVR, THV-in-THV, or surgical explantation - for the Medical-Management comparator cohort.
- For all cohorts, the local Heart Team must consider the patient suitable and indicated for the planned management strategy. For retrospectively identified cases (any cohort): the index procedure was performed, or THV failure was diagnosed, on or after 1 January 2025, with data retrievable from source records, and no opposition to retrospective data use expressed by the patient or next of kin, in line with applicable French provisions. Retrospective THV-in-THV cases from REVALVE-participating centers are eligible only per the restriction described in Section 3.3. Signed informed consent is required for prospective cases; non[MZ22.1]-opposition applies to retrospective cases
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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