NCT05172960ClinicalTrials.gov

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

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En resumen

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

De intervención1234 participantes buscados65 centros4 países

Categorías

Cardiovascular100%

Registrado en 1 registro

ClinicalTrials.govNCT05172960Abrir este registro en ClinicalTrials.govSincronizado hace 3 semanas

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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 2022-06-20
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 1 condition.
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: 65 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

ScaleLARGE

A large study, international in scope: 1,234 participants (target), run at 65 sites, across 4 countries.

How this score is built

Enrolment31/40
1,234 participants (target)
Site count21/25
65 sites
Country count7/15
4 countries
Planned duration10/10
Planned over about 177 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.

Resumen

This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.

Afecciones

Aortic Stenosis, Severe

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	No indicado en el registro
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

Inclusion Criteria: 1. Severe, calcific AS 2. Native aortic annulus size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. 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. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position 4. Severe aortic regurgitation (\> 3+) 5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis 6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months 7. Left ventricular ejection fraction \< 20% 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation 10. Increased risk of coronary artery obstruction after THV implantation 11. Myocardial infarction within 30 days prior to the study procedure 12. Hypertrophic cardiomyopathy with subvalvular obstruction 13. Subjects with planned concomitant ablation for atrial fibrillation 14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI) 15. Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion. 16. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD) 17. Endocarditis within 180 days prior to the study procedure 18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure 19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure 20. Renal insufficiency and/or renal replacement therapy 21. Leukopenia, anemia, thrombocytopenia 22. Inability to tolerate or condition precluding treatment with antithrombotic therapy 23. Hypercoagulable state or other condition that increases risk of thrombosis 24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 25. Subject refuses blood products 26. BMI \> 50 kg/m2 27. Estimated life expectancy \< 24 months 28. Female who is pregnant or lactating 29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 30. Participating in another investigational drug or device study that has not reached its primary endpoint 31. Subject considered to be part of a vulnerable population

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	No aplicable
Asignación	No aleatorizado
Modelo de intervención	SINGLE_GROUP
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	1234 participantes buscados

Patrocinador y colaboradores

Edwards Lifesciences Patrocinador

Grupos e intervenciones

TAVR - Main CohortEXPERIMENTAL
Subjects will undergo transcatheter aortic valve replacement (TAVR)
TAVR - Bicuspid RegistryEXPERIMENTAL
Subjects with bicuspid aortic valve morphology will undergo TAVR
TAVR - X4S RegistryEXPERIMENTAL
Subjects will undergo transcatheter aortic valve replacement (TAVR)

Intervenciones

Dispositivo SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Dispositivo SAPIEN X4S
Implantation of the SAPIEN X4S valve

Variables de resultado

Variable de resultado principal
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Plazo 1 year
Variable de resultado secundaria
Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline
The number of patients that met all of these criteria. 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.
Plazo 1 year
Variable de resultado secundaria
Paravalvular leak
Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe
Plazo 30 days
Variable de resultado secundaria
New permanent pacemaker implantation
The number of patients with this event
Plazo 30 days

Fechas

Fechas
Fecha de inicio	20 de junio de 2022 (real)
Finalización principal	1 de julio de 2027 (estimada)
Finalización	1 de enero de 2037 (estimada)
Primera publicación	29 de diciembre de 2021 (real)
Última actualización	3 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	agosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

26 centros están en reclutamiento

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Royal Adelaide Hospital	Adelaide	South Australia	Activo, sin reclutar
The Royal Melbourne Hospital	Parkville		Activo, sin reclutar
St. Andrews War Memorial Hospital	Spring Hill	Queensland	Activo, sin reclutar

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Hamilton Health Services	Hamilton	Ontario	Activo, sin reclutar
Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval	Québec	Quebec	Activo, sin reclutar
St. Paul's Hospital System	Vancouver	British Columbia	Activo, sin reclutar

New Zealand

New Zealand
Centro	Ciudad	Estado o región	Estado
Christchurch Hospital	Christchurch		Activo, sin reclutar

United States

United States
Centro	Ciudad	Estado o región	Estado
Piedmont Heart Institute	Atlanta	Georgia	Activo, sin reclutar
Emory University Atlanta	Atlanta	Georgia	Activo, sin reclutar
Medstar Union Memorial Hospital	Baltimore	Maryland	En reclutamiento
Brigham and Women's Hospital	Boston	Massachusetts	En reclutamiento
University at Buffalo - Kaleida Health	Buffalo	New York	En reclutamiento
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC	Carmel	Indiana	Activo, sin reclutar
Carolinas Health System	Charlotte	North Carolina	Activo, sin reclutar
Novant Health and Heart Vascular Institute	Charlotte	North Carolina	En reclutamiento
Rush University Medical Center Chicago	Chicago	Illinois	Activo, sin reclutar
The Christ Hospital	Cincinnati	Ohio	En reclutamiento
Kaiser Portland	Clackamas	Oregon	En reclutamiento
The Cleveland Clinic Foundation	Cleveland	Ohio	Activo, sin reclutar
Medical City Dallas Hospital	Dallas	Texas	Activo, sin reclutar
Baylor Heart and Vascular Hospital	Dallas	Texas	En reclutamiento
Henry Ford Hospital	Detroit	Michigan	Activo, sin reclutar
Alexian Brothers Hospital Network	Elk Grove Village	Illinois	En reclutamiento
NorthShore University HealthSystem Research Institute Evanston	Evanston	Illinois	En reclutamiento
Northwestern University Chicago	Evanston	Illinois	En reclutamiento
Methodist Le Bonheur Healthcare	Germantown	Tennessee	Activo, sin reclutar
Pinnacle Health Harrisburg	Harrisburg	Pennsylvania	Completado
Hartford Hospital	Hartford	Connecticut	Activo, sin reclutar
HCA Houston Healthcare Medical Center	Houston	Texas	Activo, sin reclutar
University of Texas Memorial Hermann	Houston	Texas	Activo, sin reclutar
University of Kansas Medical Center	Kansas City	Kansas	Activo, sin reclutar
Saint Luke's Hospital	Kansas City	Missouri	Activo, sin reclutar
Scripps Memorial Hospital La Jolla	La Jolla	California	Activo, sin reclutar
Dartmouth-Hitchcock Medical Center, Hanover	Lebanon	New Hampshire	En reclutamiento
Kaiser Los Angeles	Los Angeles	California	Activo, sin reclutar
Cedars-Sinai Medical Center	Los Angeles	California	En reclutamiento
UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado	Activo, sin reclutar
St. Patrick Hospital	Missoula	Montana	Activo, sin reclutar
Atlantic Health System Morristown	Morristown	New Jersey	En reclutamiento
Centennial Medical Center	Nashville	Tennessee	En reclutamiento
Saint Thomas Health	Nashville	Tennessee	En reclutamiento
Vanderbilt University Medical Center	Nashville	Tennessee	En reclutamiento
Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	En reclutamiento
Silver Cross Hospital	New Lenox	Illinois	En reclutamiento
Columbia University Medical Center/NYPH	New York	New York	En reclutamiento
Cornell Medical Center	New York	New York	En reclutamiento
Montefiore Medical Center	New York	New York	Activo, sin reclutar
Hoag Memorial Hospital Presbyterian	Newport Beach	California	Activo, sin reclutar
Sentara Norfolk General Hospital	Norfolk	Virginia	Activo, sin reclutar
Naples Community Hospital Healthcare System	North Naples	Florida	Activo, sin reclutar

En el registro figuran 15 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05172960