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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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.

تدخّليةمطلوب 200 مشارك36 موقعاًدولتان

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT05172973فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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هل أنت مهتم بهذه الدراسة؟

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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.

ملخص

Prospective, single arm, multicenter study

الحالات

Aortic Valve Insufficiency
Aortic Valve Stenosis

الأهلية

الأهلية
الجنس	الجميع
الأعمار	غير مذكور في سجل السجل
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	غير منطبق
التخصيص	غير معشّاة
نموذج التدخّل	SINGLE_GROUP
الغرض الأساسي	TREATMENT
التعمية	NONE (0)
التجنيد	مطلوب 200 مشارك

الجهة الراعية والمتعاونون

Edwards Lifesciences الجهة الراعية

الأذرع والتدخلات

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).

التدخلات

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

مقاييس النتائج

مقياس النتيجة الأولي
Non-hierarchical composite of death and stroke
The number of patients that died or had a stroke
الإطار الزمني 1 year
مقياس النتيجة الثانوي
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.
الإطار الزمني 30 days
مقياس النتيجة الثانوي
KCCQ score
الإطار الزمني 1 year
مقياس النتيجة الثانوي
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.
الإطار الزمني 30 days
مقياس النتيجة الثانوي
NYHA functional class
الإطار الزمني 1 year

التواريخ

التواريخ
تاريخ البدء	22 نوفمبر 2023 (فعلي)
الإتمام الأولي	1 مارس 2029 (تقديري)
الإتمام	1 ديسمبر 2039 (تقديري)
أول نشر	29 ديسمبر 2021 (فعلي)
آخر تحديث	27 يوليو 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	يونيو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

35 موقعاً قيد التجنيد

Canada

Canada
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Hamilton Health Sciences	Hamilton	Ontario	قيد التجنيد
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval	Québec	Quebec	قيد التجنيد
St. Paul's Hospital Vancouver	Vancouver	British Columbia	قيد التجنيد

United States

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

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

27 يوليو 2026
تأخّر تاريخ الإتمام
Primary completion delayed 821 days
2026-12-012029-03-01
27 يوليو 2026
أُضيف موقع
1 site added (36 total)
3536

السجل: ClinicalTrials.gov · NCT########

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