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

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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 who are at high or greater risk with a failing aortic bioprosthetic valve.

De intervención200 participantes buscados36 centros2 países

Categorías

Cardiovascular100%

Registrado en 1 registro

ClinicalTrials.govNCT05172973Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

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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.

Resumen

Prospective, single arm, multicenter study

Afecciones

Aortic Valve Insufficiency
Aortic Valve Stenosis

Elegibilidad

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

Elegibilidad tal como figura en el registro

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

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	200 participantes buscados

Patrocinador y colaboradores

Edwards Lifesciences Patrocinador

Grupos e intervenciones

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).

Intervenciones

Dispositivo SAPIEN X4/X4S THV
Implantation of the SAPIEN X4/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
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.
Plazo 30 days
Variable de resultado secundaria
KCCQ score
Plazo 1 year
Variable de resultado secundaria
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.
Plazo 30 days
Variable de resultado secundaria
NYHA functional class
Plazo 1 year

Fechas

Fechas
Fecha de inicio	22 de noviembre de 2023 (real)
Finalización principal	1 de marzo de 2029 (estimada)
Finalización	1 de diciembre de 2039 (estimada)
Primera publicación	29 de diciembre de 2021 (real)
Última actualización	27 de julio de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	junio de 2026

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

Ubicaciones

35 centros están en reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Hamilton Health Sciences	Hamilton	Ontario	En reclutamiento
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval	Québec	Quebec	En reclutamiento
St. Paul's Hospital Vancouver	Vancouver	British Columbia	En reclutamiento

United States

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

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

27 de julio de 2026
Fecha de finalización aplazada
Primary completion delayed 821 days
2026-12-012029-03-01
27 de julio de 2026
Centro añadido
1 site added (36 total)
3536

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

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