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

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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 with symptomatic, severe, calcific aortic stenosis (AS).

Interventionell1.234 Teilnehmende gesucht65 Studienzentren4 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT05172960Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 3 Wochen

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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 2022-06-20
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 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.

Zusammenfassung

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

Erkrankungen

Aortic Stenosis, Severe

Eignung

Eignung
Geschlecht	Alle
Alter	Im Registereintrag nicht angegeben
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

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	1.234 Teilnehmende gesucht

Sponsor und Mitwirkende

Edwards Lifesciences Sponsor

Studienarme und Interventionen

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)

Interventionen

Medizinprodukt SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Medizinprodukt SAPIEN X4S
Implantation of the SAPIEN 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
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.
Zeitrahmen 1 year
Sekundärer Endpunkt
Paravalvular leak
Paravalvular leak will be categorized as None, Trace, Mild, Mild-Moderate, Moderate, Moderate-Severe, or Severe
Zeitrahmen 30 days
Sekundärer Endpunkt
New permanent pacemaker implantation
The number of patients with this event
Zeitrahmen 30 days

Daten

Daten
Startdatum	20. Juni 2022 (tatsächlich)
Primärer Abschluss	1. Juli 2027 (geschätzt)
Abschluss	1. Januar 2037 (geschätzt)
Erstveröffentlichung	29. Dezember 2021 (tatsächlich)
Zuletzt aktualisiert	3. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

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

Standorte

26 Studienzentren rekrutieren

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Royal Adelaide Hospital	Adelaide	South Australia	Aktiv, rekrutiert nicht
The Royal Melbourne Hospital	Parkville		Aktiv, rekrutiert nicht
St. Andrews War Memorial Hospital	Spring Hill	Queensland	Aktiv, rekrutiert nicht

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Hamilton Health Services	Hamilton	Ontario	Aktiv, rekrutiert nicht
Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval	Québec	Quebec	Aktiv, rekrutiert nicht
St. Paul's Hospital System	Vancouver	British Columbia	Aktiv, rekrutiert nicht

New Zealand

New Zealand
Einrichtung	Stadt	Bundesland oder Region	Status
Christchurch Hospital	Christchurch		Aktiv, rekrutiert nicht

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Piedmont Heart Institute	Atlanta	Georgia	Aktiv, rekrutiert nicht
Emory University Atlanta	Atlanta	Georgia	Aktiv, rekrutiert nicht
Medstar Union Memorial Hospital	Baltimore	Maryland	Rekrutiert
Brigham and Women's Hospital	Boston	Massachusetts	Rekrutiert
University at Buffalo - Kaleida Health	Buffalo	New York	Rekrutiert
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC	Carmel	Indiana	Aktiv, rekrutiert nicht
Carolinas Health System	Charlotte	North Carolina	Aktiv, rekrutiert nicht
Novant Health and Heart Vascular Institute	Charlotte	North Carolina	Rekrutiert
Rush University Medical Center Chicago	Chicago	Illinois	Aktiv, rekrutiert nicht
The Christ Hospital	Cincinnati	Ohio	Rekrutiert
Kaiser Portland	Clackamas	Oregon	Rekrutiert
The Cleveland Clinic Foundation	Cleveland	Ohio	Aktiv, rekrutiert nicht
Medical City Dallas Hospital	Dallas	Texas	Aktiv, rekrutiert nicht
Baylor Heart and Vascular Hospital	Dallas	Texas	Rekrutiert
Henry Ford Hospital	Detroit	Michigan	Aktiv, rekrutiert nicht
Alexian Brothers Hospital Network	Elk Grove Village	Illinois	Rekrutiert
NorthShore University HealthSystem Research Institute Evanston	Evanston	Illinois	Rekrutiert
Northwestern University Chicago	Evanston	Illinois	Rekrutiert
Methodist Le Bonheur Healthcare	Germantown	Tennessee	Aktiv, rekrutiert nicht
Pinnacle Health Harrisburg	Harrisburg	Pennsylvania	Abgeschlossen
Hartford Hospital	Hartford	Connecticut	Aktiv, rekrutiert nicht
HCA Houston Healthcare Medical Center	Houston	Texas	Aktiv, rekrutiert nicht
University of Texas Memorial Hermann	Houston	Texas	Aktiv, rekrutiert nicht
University of Kansas Medical Center	Kansas City	Kansas	Aktiv, rekrutiert nicht
Saint Luke's Hospital	Kansas City	Missouri	Aktiv, rekrutiert nicht
Scripps Memorial Hospital La Jolla	La Jolla	California	Aktiv, rekrutiert nicht
Dartmouth-Hitchcock Medical Center, Hanover	Lebanon	New Hampshire	Rekrutiert
Kaiser Los Angeles	Los Angeles	California	Aktiv, rekrutiert nicht
Cedars-Sinai Medical Center	Los Angeles	California	Rekrutiert
UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado	Aktiv, rekrutiert nicht
St. Patrick Hospital	Missoula	Montana	Aktiv, rekrutiert nicht
Atlantic Health System Morristown	Morristown	New Jersey	Rekrutiert
Centennial Medical Center	Nashville	Tennessee	Rekrutiert
Saint Thomas Health	Nashville	Tennessee	Rekrutiert
Vanderbilt University Medical Center	Nashville	Tennessee	Rekrutiert
Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	Rekrutiert
Silver Cross Hospital	New Lenox	Illinois	Rekrutiert
Columbia University Medical Center/NYPH	New York	New York	Rekrutiert
Cornell Medical Center	New York	New York	Rekrutiert
Montefiore Medical Center	New York	New York	Aktiv, rekrutiert nicht
Hoag Memorial Hospital Presbyterian	Newport Beach	California	Aktiv, rekrutiert nicht
Sentara Norfolk General Hospital	Norfolk	Virginia	Aktiv, rekrutiert nicht
Naples Community Hospital Healthcare System	North Naples	Florida	Aktiv, rekrutiert nicht

15 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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