NCT05172973ClinicalTrials.gov

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Interventionnelle200 participants recherchés36 sites2 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT05172973Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2021-12-29; recorded start 2023-11-22
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 47 other studies in this databaseCounted from the lead sponsor named in the record (Edwards Lifesciences)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Non-randomised allocation
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 35 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 200 participants (target), run at 36 sites, across 2 countries.

How this score is built

Enrolment22/40
200 participants (target)
Site count18/25
35 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 148 months
Sponsor scale6/10
Edwards Lifesciences has led 47 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

Prospective, single arm, multicenter study

Affections

Aortic Valve Insufficiency
Aortic Valve Stenosis

Éligibilité

Éligibilité
Sexe	Tous
Âges	Non précisé dans la fiche du registre
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: 1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency 2. Bioprosthetic valve size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. Heart Team agrees the subject is at high or greater surgical risk 5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system 2. Failing valve has moderate or severe paravalvular regurgitation 3. Failing valve is unstable, rocking, or not structurally intact 4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve 5. Increased risk of THV embolization 6. Surgical or transcatheter valve in the mitral position 7. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis 8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months 9. Left ventricular ejection fraction \< 20% 10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 11. Increased risk of coronary artery obstruction after THV implantation 12. Myocardial infarction within 30 days prior to the study procedure 13. Hypertrophic cardiomyopathy with subvalvular obstruction 14. Subjects with planned concomitant ablation for atrial fibrillation 15. Clinically significant coronary artery disease requiring revascularization 16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion. 17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure 18. Endocarditis within 180 days prior to the study procedure 19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure 20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure 21. Renal insufficiency and/or renal replacement therapy 22. Leukopenia, anemia, thrombocytopenia 23. Inability to tolerate or condition precluding treatment with antithrombotic therapy 24. Hypercoagulable state or other condition that increases risk of thrombosis 25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 26. Subject refuses blood products 27. Body mass index \> 50 kg/m2 28. Estimated life expectancy \< 24 months 29. Female who is pregnant or lactating 30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 31. Participating in another investigational drug or device study that has not reached its primary endpoint 32. Subject considered to be part of a vulnerable population

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Sans objet
Répartition	Non randomisée
Modèle d'intervention	SINGLE_GROUP
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	200 participants recherchés

Promoteur et collaborateurs

Edwards Lifesciences Promoteur

Groupes et interventions

Transcatheter Aortic Valve Replacement (TAVR) - Surgical ValveEXPERIMENTAL
TAVR implant in subjects with a failing aortic surgical valve.
Transcatheter Aortic Valve Replacement (TAVR) - THVEXPERIMENTAL
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).

Interventions

Dispositif SAPIEN X4/X4S THV
Implantation of the SAPIEN X4/X4S valve

Critères de jugement

Critère de jugement principal
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Délai 1 year
Critère de jugement secondaire
Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Délai 30 days
Critère de jugement secondaire
KCCQ score
Délai 1 year
Critère de jugement secondaire
New York Heart Association (NYHA) functional class
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Délai 30 days
Critère de jugement secondaire
NYHA functional class
Délai 1 year

Dates

Dates
Date de début	22 novembre 2023 (réelle)
Achèvement principal	1 mars 2029 (estimée)
Achèvement	1 décembre 2039 (estimée)
Première publication	29 décembre 2021 (réelle)
Dernière mise à jour	27 juillet 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	juin 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

35 sites sont en recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
Hamilton Health Sciences	Hamilton	Ontario	En recrutement
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval	Québec	Quebec	En recrutement
St. Paul's Hospital Vancouver	Vancouver	British Columbia	En recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Piedmont Heart Institute	Atlanta	Georgia	En recrutement
Emory University Atlanta	Atlanta	Georgia	En recrutement
MedStar Union Memorial Hospital	Baltimore	Maryland	En recrutement
Brigham and Women's Hospital	Boston	Massachusetts	En recrutement
University of Buffalo	Buffalo	New York	En recrutement
Novant Health and Vascular Institute	Charlotte	North Carolina	En recrutement
Carolinas Health System	Charlotte	North Carolina	En recrutement
The Christ Hospital	Cincinnati	Ohio	En recrutement
The Cleveland Clinic Foundation	Cleveland	Ohio	En recrutement
Henry Ford Hospital Detroit	Detroit	Michigan	En recrutement
Northwestern University Chicago	Evanston	Illinois	En recrutement
University of Texas Memorial Hermann	Houston	Texas	En recrutement
Alexian Brothers Hospital Network	Lisle	Illinois	En recrutement
UC Health Medical Center of the Rockies	Loveland	Colorado	En recrutement
Atlantic Health System Morristown	Morristown	New Jersey	En recrutement
Naples Community Hospital Healthcare System	Naples	Florida	En recrutement
Saint Thomas Health	Nashville	Tennessee	En recrutement
Robert Wood Johnson University Hospital	New Brunswick	New Jersey	En recrutement
Columbia University Medical Center / NYPH	New York	New York	En recrutement
Montefiore Medical Center	New York	New York	En recrutement
Cornelll University New York	New York	New York	En recrutement
Hoag Memorial Hospital Presbyterian	Newport Beach	California	En recrutement
Allegheny General Hospital	Pittsburgh	Pennsylvania	En recrutement
The Heart Hospital Baylor Plano	Plano	Texas	En recrutement
The Valley Hospital	Ridgewood	New Jersey	En recrutement
Rochester General Hospital	Rochester	New York	En recrutement
Mayo Clinic	Rochester	Minnesota	En recrutement
Kaiser San Francisco	San Francisco	California	En recrutement
Bay Area Structural Heart at Sutter Health	San Francisco	California	En recrutement
University of Washington Seattle	Seattle	Washington	Retiré
Stanford University Medical Center	Stanford	California	En recrutement
Oklahoma Heart Institute	Tulsa	Oklahoma	En recrutement
Cardiovascular Research Institute of Kansas	Wichita	Kansas	En recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

27 juillet 2026
Date d'achèvement reportée
Primary completion delayed 821 days
2026-12-012029-03-01
27 juillet 2026
Site ajouté
1 site added (36 total)
3536

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05172973