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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

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

Interventional200 participants sought36 sites2 countries

Categories

Cardiovascular100%

Registered in 1 registry

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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 2023-11-22
  • 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 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.

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

Prospective, single arm, multicenter study

Conditions

  • Aortic Valve Insufficiency
  • Aortic Valve Stenosis

Eligibility

SexAll
AgesNot stated in the registry record
Healthy volunteersNo

Eligibility as written in the registry

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

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)
Enrolment200 participants sought

Sponsor and collaborators

  • Edwards Lifesciences Sponsor

Arms and 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

  • Device SAPIEN X4/X4S THV

    Implantation of the SAPIEN X4/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

    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.

    Time frame 30 days

  3. Secondary outcome

    KCCQ score

    Time frame 1 year

  4. Secondary outcome

    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.

    Time frame 30 days

  5. Secondary outcome

    NYHA functional class

    Time frame 1 year

Dates

Start dateNovember 22, 2023 (actual)
Primary completionMarch 1, 2029 (estimated)
CompletionDecember 1, 2039 (estimated)
First postedDecember 29, 2021 (actual)
Last updatedJuly 27, 2026
Results postedNot stated in the registry record
Status last verifiedJune 2026

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

Locations

35 sites are recruiting

Canada

FacilityCityState or regionStatus
Hamilton Health SciencesHamiltonOntarioRecruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite LavalQuébecQuebecRecruiting
St. Paul's Hospital VancouverVancouverBritish ColumbiaRecruiting

United States

FacilityCityState or regionStatus
Piedmont Heart InstituteAtlantaGeorgiaRecruiting
Emory University AtlantaAtlantaGeorgiaRecruiting
MedStar Union Memorial HospitalBaltimoreMarylandRecruiting
Brigham and Women's HospitalBostonMassachusettsRecruiting
University of BuffaloBuffaloNew YorkRecruiting
Novant Health and Vascular InstituteCharlotteNorth CarolinaRecruiting
Carolinas Health SystemCharlotteNorth CarolinaRecruiting
The Christ HospitalCincinnatiOhioRecruiting
The Cleveland Clinic FoundationClevelandOhioRecruiting
Henry Ford Hospital DetroitDetroitMichiganRecruiting
Northwestern University ChicagoEvanstonIllinoisRecruiting
University of Texas Memorial HermannHoustonTexasRecruiting
Alexian Brothers Hospital NetworkLisleIllinoisRecruiting
UC Health Medical Center of the RockiesLovelandColoradoRecruiting
Atlantic Health System MorristownMorristownNew JerseyRecruiting
Naples Community Hospital Healthcare SystemNaplesFloridaRecruiting
Saint Thomas HealthNashvilleTennesseeRecruiting
Robert Wood Johnson University HospitalNew BrunswickNew JerseyRecruiting
Columbia University Medical Center / NYPHNew YorkNew YorkRecruiting
Montefiore Medical CenterNew YorkNew YorkRecruiting
Cornelll University New YorkNew YorkNew YorkRecruiting
Hoag Memorial Hospital PresbyterianNewport BeachCaliforniaRecruiting
Allegheny General HospitalPittsburghPennsylvaniaRecruiting
The Heart Hospital Baylor PlanoPlanoTexasRecruiting
The Valley HospitalRidgewoodNew JerseyRecruiting
Rochester General HospitalRochesterNew YorkRecruiting
Mayo ClinicRochesterMinnesotaRecruiting
Kaiser San FranciscoSan FranciscoCaliforniaRecruiting
Bay Area Structural Heart at Sutter HealthSan FranciscoCaliforniaRecruiting
University of Washington SeattleSeattleWashingtonWithdrawn
Stanford University Medical CenterStanfordCaliforniaRecruiting
Oklahoma Heart InstituteTulsaOklahomaRecruiting
Cardiovascular Research Institute of KansasWichitaKansasRecruiting

Study documents

No documents are linked in this registry record.

Changes over time

  1. July 27, 2026

    Completion date moved later

    Primary completion delayed 821 days

    2026-12-012029-03-01

  2. July 27, 2026

    Site added

    1 site added (36 total)

    3536

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

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