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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

RecruitingTaking participants now, according to the registry record.
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In brief

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).

Interventional1,234 participants sought65 sites4 countries

Categories

Cardiovascular100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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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.

Summary

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.

Conditions

  • Aortic Stenosis, Severe

Eligibility

SexAll
AgesNot stated in the registry record
Healthy volunteersNo

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhaseNot applicable
AllocationNon-randomised
Intervention modelSINGLE_GROUP
Primary purposeTREATMENT
MaskingNONE (0)
Enrolment1,234 participants sought

Sponsor and collaborators

  • Edwards Lifesciences Sponsor

Arms and interventions

  • 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)

Interventions

  • Device SAPIEN X4 THV

    Implantation of the SAPIEN X4 valve

  • Device SAPIEN X4S

    Implantation of the SAPIEN X4S valve

Outcome measures

  1. Primary outcome

    Non-hierarchical composite of death and stroke

    The number of patients that died or had a stroke

    Time frame 1 year

  2. Secondary outcome

    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.

    Time frame 1 year

  3. Secondary outcome

    Paravalvular leak

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

    Time frame 30 days

  4. Secondary outcome

    New permanent pacemaker implantation

    The number of patients with this event

    Time frame 30 days

Dates

Start dateJune 20, 2022 (actual)
Primary completionJuly 1, 2027 (estimated)
CompletionJanuary 1, 2037 (estimated)
First postedDecember 29, 2021 (actual)
Last updatedSeptember 3, 2026
Results postedNot stated in the registry record
Status last verifiedAugust 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

26 sites are recruiting

Australia

FacilityCityState or regionStatus
Royal Adelaide HospitalAdelaideSouth AustraliaActive, not recruiting
The Royal Melbourne HospitalParkvilleActive, not recruiting
St. Andrews War Memorial HospitalSpring HillQueenslandActive, not recruiting

Canada

FacilityCityState or regionStatus
Hamilton Health ServicesHamiltonOntarioActive, not recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite LavalQuébecQuebecActive, not recruiting
St. Paul's Hospital SystemVancouverBritish ColumbiaActive, not recruiting

New Zealand

FacilityCityState or regionStatus
Christchurch HospitalChristchurchActive, not recruiting

United States

FacilityCityState or regionStatus
Piedmont Heart InstituteAtlantaGeorgiaActive, not recruiting
Emory University AtlantaAtlantaGeorgiaActive, not recruiting
Medstar Union Memorial HospitalBaltimoreMarylandRecruiting
Brigham and Women's HospitalBostonMassachusettsRecruiting
University at Buffalo - Kaleida HealthBuffaloNew YorkRecruiting
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLCCarmelIndianaActive, not recruiting
Carolinas Health SystemCharlotteNorth CarolinaActive, not recruiting
Novant Health and Heart Vascular InstituteCharlotteNorth CarolinaRecruiting
Rush University Medical Center ChicagoChicagoIllinoisActive, not recruiting
The Christ HospitalCincinnatiOhioRecruiting
Kaiser PortlandClackamasOregonRecruiting
The Cleveland Clinic FoundationClevelandOhioActive, not recruiting
Medical City Dallas HospitalDallasTexasActive, not recruiting
Baylor Heart and Vascular HospitalDallasTexasRecruiting
Henry Ford HospitalDetroitMichiganActive, not recruiting
Alexian Brothers Hospital NetworkElk Grove VillageIllinoisRecruiting
NorthShore University HealthSystem Research Institute EvanstonEvanstonIllinoisRecruiting
Northwestern University ChicagoEvanstonIllinoisRecruiting
Methodist Le Bonheur HealthcareGermantownTennesseeActive, not recruiting
Pinnacle Health HarrisburgHarrisburgPennsylvaniaCompleted
Hartford HospitalHartfordConnecticutActive, not recruiting
HCA Houston Healthcare Medical CenterHoustonTexasActive, not recruiting
University of Texas Memorial HermannHoustonTexasActive, not recruiting
University of Kansas Medical CenterKansas CityKansasActive, not recruiting
Saint Luke's HospitalKansas CityMissouriActive, not recruiting
Scripps Memorial Hospital La JollaLa JollaCaliforniaActive, not recruiting
Dartmouth-Hitchcock Medical Center, HanoverLebanonNew HampshireRecruiting
Kaiser Los AngelesLos AngelesCaliforniaActive, not recruiting
Cedars-Sinai Medical CenterLos AngelesCaliforniaRecruiting
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoActive, not recruiting
St. Patrick HospitalMissoulaMontanaActive, not recruiting
Atlantic Health System MorristownMorristownNew JerseyRecruiting
Centennial Medical CenterNashvilleTennesseeRecruiting
Saint Thomas HealthNashvilleTennesseeRecruiting
Vanderbilt University Medical CenterNashvilleTennesseeRecruiting
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew JerseyRecruiting
Silver Cross HospitalNew LenoxIllinoisRecruiting
Columbia University Medical Center/NYPHNew YorkNew YorkRecruiting
Cornell Medical CenterNew YorkNew YorkRecruiting
Montefiore Medical CenterNew YorkNew YorkActive, not recruiting
Hoag Memorial Hospital PresbyterianNewport BeachCaliforniaActive, not recruiting
Sentara Norfolk General HospitalNorfolkVirginiaActive, not recruiting
Naples Community Hospital Healthcare SystemNorth NaplesFloridaActive, not recruiting

15 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

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