SAVR
est développé par Alexandria University.
Le traitement est actuellement en À vérifier.
Il est associé à Maladie coronarienne.
Son objectif thérapeutique principal est À vérifier.
Le statut actuel est : suivi actif.
À vérifier
À vérifier
À vérifier
Alexandria University
Egypt
\# WHAT IS THIS STUDY ABOUT?
This study compares two different treatment approaches for patients with two heart conditions occurring simultaneously: a narrowed heart valve (aortic stenosis) and narrowed or blocked heart arteries (coronary artery disease). Both conditions are serious and, when they occur together, place considerable strain on the heart. The heart must work harder to pump blood through the narrowed valve while simultaneously receiving an inadequate blood supply through the blocked coronary arteries.
\# WHY IS THIS STUDY NEEDED?
Until recently, the main treatment option for patients with both conditions was open-heart surgery. This major operation involves opening the chest, temporarily stopping the heart, replacing the heart valve with an artificial valve, and performing coronary artery bypass grafting to restore blood flow around the blocked arteries. Although effective, combined surgery carries significant risks, particularly in older or frailer patients, including prolonged recovery, longer hospital stays (often 2 to 3 weeks), bleeding, kidney injury, and other complications.
A newer, less invasive treatment approach is now available. This involves replacing the heart valve through a thin tube (catheter) inserted through a blood vessel in the groin, without opening the chest, and treating the blocked coronary arteries using a fine wire, a small balloon, and a metal mesh tube (stent) placed inside the artery. This approach, known as transcatheter aortic valve implantation (TAVI) combined with percutaneous coronary intervention (PCI), typically requires a shorter hospital stay of approximately 2 to 4 days and may allow an earlier return to normal activities.
However, sufficient evidence from well-designed studies is not yet available to establish whether this less invasive approach is as safe and effective as conventional surgery in patients who are not considered at high surgical risk.
This study aims to address this evidence gap.
\# WHO CAN JOIN THIS STUDY?
Adults with severe aortic stenosis and significant coronary artery disease who have been assessed by a specialist heart team as having low or intermediate surgical risk may be eligible to participate.
All participants must be considered suitable for both the catheter-based treatment approach and the surgical approach, based on individual coronary anatomy, clinical characteristics, and medical history.
Patients with previous coronary artery bypass graft surgery, severely impaired left ventricular systolic function (ejection fraction below 40%), or a recent myocardial infarction within the previous 6 months are not eligible to participate.
* WHAT WILL HAPPEN IF A PATIENT JOINS THE STUDY?
Participants will receive one of two treatment approaches, selected by a specialist heart team according to individual coronary and valvular anatomy, clinical circumstances, and patient preference:
1. Catheter-based aortic valve replacement combined with coronary artery stenting (TAVI + PCI).
2. Conventional open-heart surgery involving surgical aortic valve replacement and coronary artery bypass grafting (SAVR + CABG).
Regardless of the treatment received, all participants will undergo follow-up assessments at hospital discharge, 30 days, 6 months, and 1 year after the procedure. Follow-up will include clinical assessments and appropriate cardiac investigations.
* WHAT IS THE STUDY MEASURING?
The study will evaluate the incidence of major complications, including all-cause mortality, myocardial infarction, stroke, serious bleeding, and the need for urgent repeat intervention, during the index hospitalization and within 1 year after the procedure.
Additional outcomes will include recovery duration, length of hospital stay, and changes in kidney function.
* WHERE IS THE STUDY TAKING PLACE?
The study is being conducted at Alexandria University Hospitals and other major cardiac centres across Egypt, with a planned total enrolment of 100 participants.
\# WHO IS CONDUCTING THE STUDY?
The study is being conducted by Dr. Moustafa AbdelMohsen Elsayed Madkour, Department of Cardiology and Angiology, Faculty of Medicine, Alexandria University, Egypt, under the supervision of Prof. Dr. Mohamed Ahmed Sobhy and Prof. Dr. Tarek Hussien Elzawawy.
2026-11-05
Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique
À vérifier
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé
Objectif scientifique de l’étude
classification automatique vérifiable
À vérifierConfiance automatique : 0%
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT07926022, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Contrôle de cohérence : 85/100
L’objectif est absent ou classé « Autre » et doit être recalculé à partir du protocole.
Transparence et qualité de la fiche
données vérifiables
ClassificationÀ vérifier
Confiance de la fiche85 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-11-05
Anomalies détectées1
Validation humaineValidation humaine non effectuée
Donnée issue d’une sourceDonnée normalisée automatiquementInterprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultat
État de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectif
Phase enregistréeÀ vérifier
Études associées1
Publications associées0
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
4 événement(s) daté(s)
Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.