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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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).

Interventistico1234 partecipanti ricercati65 centri4 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

  • Registered before enrolment beganFirst posted 2021-12-29; recorded start 2022-06-20
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 47 other studies in this databaseCounted from the lead sponsor named in the record (Edwards Lifesciences)
  • 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.

Sintesi

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).

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

Patologie

  • Aortic Stenosis, Severe

Idoneità

SessoTutti
EtàNon indicato nella scheda del registro
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseNon applicabile
AssegnazioneNon randomizzata
Modello di interventoSINGLE_GROUP
Finalità principaleTREATMENT
MascheramentoNONE (0)
Arruolamento1234 partecipanti ricercati

Sponsor e collaboratori

  • Edwards Lifesciences Sponsor

Bracci e interventi

  • 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)

Interventi

  • Dispositivo SAPIEN X4 THV

    Implantation of the SAPIEN X4 valve

  • Dispositivo SAPIEN X4S

    Implantation of the SAPIEN X4S valve

Esiti misurati

  1. Esito primario

    Non-hierarchical composite of death and stroke

    The number of patients that died or had a stroke

    Orizzonte temporale 1 year

  2. Esito secondario

    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.

    Orizzonte temporale 1 year

  3. Esito secondario

    Paravalvular leak

    Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe

    Orizzonte temporale 30 days

  4. Esito secondario

    New permanent pacemaker implantation

    The number of patients with this event

    Orizzonte temporale 30 days

Date

Data di inizio20 giugno 2022 (effettiva)
Conclusione primaria1 luglio 2027 (stimata)
Conclusione1 gennaio 2037 (stimata)
Prima pubblicazione29 dicembre 2021 (effettiva)
Ultimo aggiornamento3 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaagosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

26 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Royal Adelaide HospitalAdelaideSouth AustraliaAttivo, non in reclutamento
The Royal Melbourne HospitalParkvilleAttivo, non in reclutamento
St. Andrews War Memorial HospitalSpring HillQueenslandAttivo, non in reclutamento

Canada

StrutturaCittàStato o regioneStato
Hamilton Health ServicesHamiltonOntarioAttivo, non in reclutamento
Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite LavalQuébecQuebecAttivo, non in reclutamento
St. Paul's Hospital SystemVancouverBritish ColumbiaAttivo, non in reclutamento

New Zealand

StrutturaCittàStato o regioneStato
Christchurch HospitalChristchurchAttivo, non in reclutamento

United States

StrutturaCittàStato o regioneStato
Piedmont Heart InstituteAtlantaGeorgiaAttivo, non in reclutamento
Emory University AtlantaAtlantaGeorgiaAttivo, non in reclutamento
Medstar Union Memorial HospitalBaltimoreMarylandIn reclutamento
Brigham and Women's HospitalBostonMassachusettsIn reclutamento
University at Buffalo - Kaleida HealthBuffaloNew YorkIn reclutamento
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLCCarmelIndianaAttivo, non in reclutamento
Carolinas Health SystemCharlotteNorth CarolinaAttivo, non in reclutamento
Novant Health and Heart Vascular InstituteCharlotteNorth CarolinaIn reclutamento
Rush University Medical Center ChicagoChicagoIllinoisAttivo, non in reclutamento
The Christ HospitalCincinnatiOhioIn reclutamento
Kaiser PortlandClackamasOregonIn reclutamento
The Cleveland Clinic FoundationClevelandOhioAttivo, non in reclutamento
Medical City Dallas HospitalDallasTexasAttivo, non in reclutamento
Baylor Heart and Vascular HospitalDallasTexasIn reclutamento
Henry Ford HospitalDetroitMichiganAttivo, non in reclutamento
Alexian Brothers Hospital NetworkElk Grove VillageIllinoisIn reclutamento
NorthShore University HealthSystem Research Institute EvanstonEvanstonIllinoisIn reclutamento
Northwestern University ChicagoEvanstonIllinoisIn reclutamento
Methodist Le Bonheur HealthcareGermantownTennesseeAttivo, non in reclutamento
Pinnacle Health HarrisburgHarrisburgPennsylvaniaCompletato
Hartford HospitalHartfordConnecticutAttivo, non in reclutamento
HCA Houston Healthcare Medical CenterHoustonTexasAttivo, non in reclutamento
University of Texas Memorial HermannHoustonTexasAttivo, non in reclutamento
University of Kansas Medical CenterKansas CityKansasAttivo, non in reclutamento
Saint Luke's HospitalKansas CityMissouriAttivo, non in reclutamento
Scripps Memorial Hospital La JollaLa JollaCaliforniaAttivo, non in reclutamento
Dartmouth-Hitchcock Medical Center, HanoverLebanonNew HampshireIn reclutamento
Kaiser Los AngelesLos AngelesCaliforniaAttivo, non in reclutamento
Cedars-Sinai Medical CenterLos AngelesCaliforniaIn reclutamento
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoAttivo, non in reclutamento
St. Patrick HospitalMissoulaMontanaAttivo, non in reclutamento
Atlantic Health System MorristownMorristownNew JerseyIn reclutamento
Centennial Medical CenterNashvilleTennesseeIn reclutamento
Saint Thomas HealthNashvilleTennesseeIn reclutamento
Vanderbilt University Medical CenterNashvilleTennesseeIn reclutamento
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew JerseyIn reclutamento
Silver Cross HospitalNew LenoxIllinoisIn reclutamento
Columbia University Medical Center/NYPHNew YorkNew YorkIn reclutamento
Cornell Medical CenterNew YorkNew YorkIn reclutamento
Montefiore Medical CenterNew YorkNew YorkAttivo, non in reclutamento
Hoag Memorial Hospital PresbyterianNewport BeachCaliforniaAttivo, non in reclutamento
Sentara Norfolk General HospitalNorfolkVirginiaAttivo, non in reclutamento
Naples Community Hospital Healthcare SystemNorth NaplesFloridaAttivo, non in reclutamento

Nella scheda del registro sono indicati altri 15 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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