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NCT04889872ClinicalTrials.gov

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects…

تدخّليةمطلوب 2,250 مشاركاً80 موقعاً6 دول

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

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

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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 2021-05-17; recorded start 2021-10-12
  • 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 randomly assignedAllocation is recorded as 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 allocation20/20

    Participants are randomly allocated between arms

  • 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 type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 80 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: 2,250 participants (target), run at 80 sites, across 6 countries.

How this score is built
  • Enrolment33/40

    2,250 participants (target)

  • Site count22/25

    80 sites

  • Country count12/15

    6 countries

  • Planned duration10/10

    Planned over about 190 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

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

الحالات

  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis

الأهلية

الجنسالجميع
الأعمار65 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Key Inclusion Criteria: 1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF \< 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

الأهلية في عبارات بسيطة

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

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةغير منطبق
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 2,250 مشاركاً

الجهة الراعية والمتعاونون

  • Edwards Lifesciences الجهة الراعية

الأذرع والتدخلات

  • TAVREXPERIMENTAL

    Transcatheter Aortic Valve Replacement (TAVR)

  • CSNO_INTERVENTION

    Clinical Surveillance (CS)

التدخلات

  • جهاز SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

    Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Primary Effectiveness Endpoint

    Non-hierarchical composite of death, and heart failure hospitalization or event

    الإطار الزمني 2 years

  2. مقياس النتيجة الأولي

    Primary Safety Endpoint

    Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention

    الإطار الزمني 30 days

  3. مقياس النتيجة الثانوي

    Death, stroke, or heart failure hospitalization

    The number of patients that had this event

    الإطار الزمني 2 years

  4. مقياس النتيجة الثانوي

    Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years

    The number of patients that met all these criteria

    الإطار الزمني 2 years

  5. مقياس النتيجة الثانوي

    Heart failure hospitalization

    The number of patients that had this event

    الإطار الزمني 2 years

  6. مقياس النتيجة الثانوي

    Left ventricle (LV) mass index

    Echocardiographic measurement of the size of the left ventricle

    الإطار الزمني 2 years

  7. مقياس النتيجة الثانوي

    Diastolic dysfunction ≥ Grade 2

    Echocardiographic measurement of the stiffness of the left ventricle.

    الإطار الزمني 2 years

التواريخ

تاريخ البدء12 أكتوبر 2021 (فعلي)
الإتمام الأولي1 يونيو 2029 (تقديري)
الإتمام1 يونيو 2037 (تقديري)
أول نشر17 مايو 2021 (فعلي)
آخر تحديث17 ديسمبر 2025
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأكتوبر 2025

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

المواقع

50 موقعاً قيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Royal Adelaide HospitalAdelaideSouth Australiaنشط، دون تجنيد
Flinders Medical CentreBedford ParkSouth Australiaنشط، دون تجنيد
The Prince Charles HospitalChermsideQueenslandنشط، دون تجنيد
Monash HealthClaytonVictoriaنشط، دون تجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Hamiton Health ServicesHamiltonOnterioنشط، دون تجنيد
St. Paul's HospitalVancouverBritish Columbiaنشط، دون تجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Sakakibara Heart InstituteFuchūTokyoنشط، دون تجنيد
Kokura Memorial HospitalFukuokaKyushuنشط، دون تجنيد
Sendai Kousei HospitalSendaiMiyagiنشط، دون تجنيد
Keio University HospitalShinjukuTokyoنشط، دون تجنيد

Netherlands

المنشأةالمدينةالولاية أو المنطقةالحالة
AMC AmsterdamAmsterdamNorth Hollandنشط، دون تجنيد
Leiden Universitair Medisch CentrumLeidenSouth Hollandنشط، دون تجنيد
Erasmus RotterdamRotterdamSouth Hollandنشط، دون تجنيد

Switzerland

المنشأةالمدينةالولاية أو المنطقةالحالة
Hôpitaux Universitaire de GenèveGenevaنشط، دون تجنيد
Universitätsspital ZürichZurichمسحوب

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Emory University AtlantaAtlantaGeorgiaقيد التجنيد
Piedmont Heart InstituteAtlantaGeorgiaقيد التجنيد
Ascension Texas CardiovascularAustinTexasقيد التجنيد
Saint AlphonsusBoiseIdahoقيد التجنيد
Massachusetts General Hospital BostonBostonMassachusettsقيد التجنيد
University of Buffalo Kaleida HealthBuffaloNew Yorkقيد التجنيد
Rush University Medical CenterChicagoIllinoisقيد التجنيد
The Christ HospitalCincinnatiOhioنشط، دون تجنيد
Kaiser Permanente NorthwestClackamasOregonنشط، دون تجنيد
Mount Carmel Health SystemColumbusOhioنشط، دون تجنيد
UT Southwestern Medical CenterDallasTexasقيد التجنيد
The Cardiac & Vascular Institute Research FoundationGainesvilleFloridaمسحوب
Methodist Le Bonheur HealthcareGermantownTennesseeقيد التجنيد
Baptist Memorial Hospital MemphisGermantownTennesseeقيد التجنيد
Moses Cone Memorial HospitalGreensboroNorth Carolinaقيد التجنيد
HCA Houston Healthcare Medical CenterHoustonTexasقيد التجنيد
The University of Texas Health Science CenterHoustonTexasقيد التجنيد
Heart Center LLC, HuntsvilleHuntsvilleAlabamaقيد التجنيد
Baptist Health Research CenterJacksonvilleFloridaقيد التجنيد
Saint Luke's Hospital of Kansas City Mid AmericaKansas CityMissouriقيد التجنيد
Parkwest Medical CenterKnoxvilleTennesseeقيد التجنيد
Mary Hitchcock Memorial HospitalLebanonNew Hampshireقيد التجنيد
Alexian Brothers HospitalLisleIllinoisقيد التجنيد
Cedars-Sinai Medical CenterLos AngelesCaliforniaقيد التجنيد
UC Health Medical Center of the RockiesLovelandColoradoقيد التجنيد
Kaiser Mid AtlanticMcLeanVirginiaقيد التجنيد
NYU Langone Hospital - Long IslandMineolaNew Yorkقيد التجنيد
Minneapolis Heart Institue, St. Paul'sMinneapolisMinnesotaقيد التجنيد
St. Patrick HospitalMissoulaMontanaنشط، دون تجنيد
Atlantic Health System Hospital Corp - Morristown Medical CenterMorristownNew Jerseyقيد التجنيد
Vanderbilt University Medical CenterNashvilleTennesseeقيد التجنيد
Saint Thomas HealthNashvilleTennesseeقيد التجنيد
Jersey Shore University Medical CenterNeptune CityNew Jerseyقيد التجنيد
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jerseyقيد التجنيد
Yale UniverstiyNew HavenConnecticutقيد التجنيد

يُدرَج 30 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

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

https://xmedica.io/trials/ctgov/NCT04889872