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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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.

Interventionell200 Teilnehmende gesucht36 Studienzentren2 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT05172973Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

Zusammenfassung

Prospective, single arm, multicenter study

Erkrankungen

Aortic Valve Insufficiency
Aortic Valve Stenosis

Eignung

Eignung
Geschlecht	Alle
Alter	Im Registereintrag nicht angegeben
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Nicht randomisiert
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	200 Teilnehmende gesucht

Sponsor und Mitwirkende

Edwards Lifesciences Sponsor

Studienarme und Interventionen

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).

Interventionen

Medizinprodukt SAPIEN X4/X4S THV
Implantation of the SAPIEN X4/X4S valve

Endpunkte

Primärer Endpunkt
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
Zeitrahmen 1 year
Sekundärer Endpunkt
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.
Zeitrahmen 30 days
Sekundärer Endpunkt
KCCQ score
Zeitrahmen 1 year
Sekundärer Endpunkt
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.
Zeitrahmen 30 days
Sekundärer Endpunkt
NYHA functional class
Zeitrahmen 1 year

Daten

Daten
Startdatum	22. November 2023 (tatsächlich)
Primärer Abschluss	1. März 2029 (geschätzt)
Abschluss	1. Dezember 2039 (geschätzt)
Erstveröffentlichung	29. Dezember 2021 (tatsächlich)
Zuletzt aktualisiert	27. Juli 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

35 Studienzentren rekrutieren

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Hamilton Health Sciences	Hamilton	Ontario	Rekrutiert
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval	Québec	Quebec	Rekrutiert
St. Paul's Hospital Vancouver	Vancouver	British Columbia	Rekrutiert

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

27. Juli 2026
Abschlussdatum nach hinten verschoben
Primary completion delayed 821 days
2026-12-012029-03-01
27. Juli 2026
Studienzentrum hinzugefügt
1 site added (36 total)
3536

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