HumRes61062
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SNCTP000005257
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BASEC2022-D0050
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NCT04889872
The PROGRESS Study: A Prospective, Randomized, Controlled Trial to Evaluate Treatment of Moderate Aortic Stenosis by Clinical Monitoring or Transcatheter Aortic Valve Replacement
Zusammenfassung der Studie
This study will evaluate the benefit of the SAPIEN 3™ and SAPIEN 3 Ultra™ transcatheter heart valves in patients with moderate, calcified aortic stenosis. Patients are randomly assigned to one of two groups in a 1:1 ratio. 1) In the treatment group, the aortic valve is replaced with the Edwards SAPIEN 3 or Edwards SAPIEN 3 Ultra system. The type of procedure for this medical device is called Transcatheter Aortic Valve Replacement (TAVR). 2) in the surveillance group, the heart valve is not replaced. However, the doctor will continue to carry out optimal drug treatment and closely monitor the state of health.
(BASEC)
Untersuchte Intervention
Aortic valve replacement using a minimally invasive surgical technique
(BASEC)
Untersuchte Krankheit(en)
moderate, calcified aortic stenosis
(BASEC)
Kriterien zur Teilnahme
• 65 years of age or older at time of randomization • Moderate AS as judged by Echo Core Lab: - Aortic valve area (AVA) / aortic valve area index (AVAi): o AVA 1.0 - 1.5 cm2; OR o AVA < 1.0 with AVAi > 0.6 cm2/m2 if BMI < 30 kg/m2; OR o AVA < 1.0 with AVAi > 0.5 cm2/m2 if BMI ≥ 30 kg/m2 AND - Peak velocity 3.0 - < 4.0 m/s OR mean gradient 20 - < 40 mmHg • The patient meets at least one of the following criteria: - Valve-related symptoms including New York Heart Association (NYHA) Functional Class ≥ II, dyspnoea, angina pectoris, dizziness, pre-syncope, or syncope considered AS-related - LVEF < 60% - Diastolic dysfunction (≥ Grade 2) according to American Society of Echocardiography1 guidelines (i.e., E/e' > 14, left atrial volume index > 34 mL/m2, or tricuspid regurgitation velocity > 2.8m/sec) - Stroke volume index < 35 mL/m2 - Persistent atrial fibrillation or an episode of paroxysmal atrial fibrillation within 6 months prior to randomisation - NT Pro BNP > 3x normal - Elevated calcium score by computed tomography (CT) Core Lab (> 1200 AU for females and > 2000 AU for males) • The subject or their legal representative has been informed of the nature of the study, agrees to the provisions and has given written informed consent. (BASEC)
Ausschlusskriterien
• Unsuitable size of native aortic annulus for THV • The aortic valve is unicuspid or noncalcified • Pre-existing mechanical or bioprosthetic aortic valve replacement • Severe aortic regurgitation (>3+) • Previous balloon aortic valvuloplasty (BAV) to treat severe aortic stenosis • LVEF < 20% • Left ventricular outflow tract (LVOT) calcification, which would increase the risk of annular rupture or significant paravalvular leak (PVL) after TAVR • Evidence of intracardiac mass, thrombus, or vegetation • Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction after TAVR • Myocardial infarction within 30 days prior to randomization • Hypertrophic cardiomyopathy with subvalvular obstruction or restrictive cardiomyopathy • Any concomitant valvular disease requiring surgical or transcatheter intervention. • Significant untreated coronary artery disease requiring revascularization • Any surgical or transcatheter procedure within 30 days prior to randomization • Active bacterial endocarditis within 180 days prior to randomization • Stroke or transient ischemic attack (TIA) within 90 days prior to randomization • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days prior to randomization • Severe chronic obstructive pulmonary disease (COPD, or currently using oxygen at home • Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to randomization • liver disease • Renal insufficiency and/or renal replacement therapy • Significant frailty • Leukopenia, anemia, thrombocytopenia • Intolerance or condition requiring treatment (BASEC)
• 65 years of age or older at time of randomization • Moderate AS as judged by Echo Core Lab: - Aortic valve area (AVA) / aortic valve area index (AVAi): o AVA 1.0 - 1.5 cm2; OR o AVA < 1.0 with AVAi > 0.6 cm2/m2 if BMI < 30 kg/m2; OR o AVA < 1.0 with AVAi > 0.5 cm2/m2 if BMI ≥ 30 kg/m2 AND - Peak velocity 3.0 - < 4.0 m/s OR mean gradient 20 - < 40 mmHg • The patient meets at least one of the following criteria: - Valve-related symptoms including New York Heart Association (NYHA) Functional Class ≥ II, dyspnoea, angina pectoris, dizziness, pre-syncope, or syncope considered AS-related - LVEF < 60% - Diastolic dysfunction (≥ Grade 2) according to American Society of Echocardiography1 guidelines (i.e., E/e' > 14, left atrial volume index > 34 mL/m2, or tricuspid regurgitation velocity > 2.8m/sec) - Stroke volume index < 35 mL/m2 - Persistent atrial fibrillation or an episode of paroxysmal atrial fibrillation within 6 months prior to randomisation - NT Pro BNP > 3x normal - Elevated calcium score by computed tomography (CT) Core Lab (> 1200 AU for females and > 2000 AU for males) • The subject or their legal representative has been informed of the nature of the study, agrees to the provisions and has given written informed consent. (BASEC)
Ausschlusskriterien
• Unsuitable size of native aortic annulus for THV • The aortic valve is unicuspid or noncalcified • Pre-existing mechanical or bioprosthetic aortic valve replacement • Severe aortic regurgitation (>3+) • Previous balloon aortic valvuloplasty (BAV) to treat severe aortic stenosis • LVEF < 20% • Left ventricular outflow tract (LVOT) calcification, which would increase the risk of annular rupture or significant paravalvular leak (PVL) after TAVR • Evidence of intracardiac mass, thrombus, or vegetation • Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction after TAVR • Myocardial infarction within 30 days prior to randomization • Hypertrophic cardiomyopathy with subvalvular obstruction or restrictive cardiomyopathy • Any concomitant valvular disease requiring surgical or transcatheter intervention. • Significant untreated coronary artery disease requiring revascularization • Any surgical or transcatheter procedure within 30 days prior to randomization • Active bacterial endocarditis within 180 days prior to randomization • Stroke or transient ischemic attack (TIA) within 90 days prior to randomization • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days prior to randomization • Severe chronic obstructive pulmonary disease (COPD, or currently using oxygen at home • Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to randomization • liver disease • Renal insufficiency and/or renal replacement therapy • Significant frailty • Leukopenia, anemia, thrombocytopenia • Intolerance or condition requiring treatment (BASEC)
Studienstandort
Genf, Zürich
(BASEC)
Australia, Canada, Japan, Netherlands, Switzerland, United States (ICTRP)
Sponsor
Edwards Lifesciences Sàrl
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. Markus Kasel
00442558599
markus.kasel@clutterusz.chUSZ Klinik für Kardiologie
(BASEC)
Allgemeine Auskünfte
Morristown Medical Center, Morristown, NJ, USA,Leiden University Medical Center, Leiden, The Netherlands,Cedars-Sinai Medical Center, Los Angeles, CA, USA,
949-250-2500
markus.kasel@clutterusz.ch(ICTRP)
Allgemeine Auskünfte
Morristown Medical Center, Morristown, NJ, USALeiden University Medical Center, Leiden, The NetherlandsCedars-Sinai Medical Center, Los Angeles, CA, USA
949-250-2500
markus.kasel@clutterusz.ch(ICTRP)
Wissenschaftliche Auskünfte
Morristown Medical Center, Morristown, NJ, USA,Leiden University Medical Center, Leiden, The Netherlands,Cedars-Sinai Medical Center, Los Angeles, CA, USA,
949-250-2500
markus.kasel@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
25.11.2022
(BASEC)
ICTRP Studien-ID
NCT04889872 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
2021-01 The PROGRESS Trial - A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement (BASEC)
Wissenschaftlicher Titel
The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement (ICTRP)
Öffentlicher Titel
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (ICTRP)
Untersuchte Krankheit(en)
Aortic Stenosis, CalcificAortic Valve Stenosis (ICTRP)
Untersuchte Intervention
Device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Primary Effectiveness Endpoint;Primary Safety Endpoint (ICTRP)
Death, stroke, or unplanned cardiovascular hospitalization;Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ);Unplanned cardiovascular hospitalization;Left ventricle (LV) mass index;Stroke volume index;Diastolic dysfunction = Grade 2;N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP);KCCQ overall score;Reduction in LVEF = 5% from baseline AND LVEF < 60%;New onset atrial fibrillation (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Philippe G?n?reux, MD;Jeroen J Bax, MD, PhD;Raj Makkar, MD;Edwards THV Clinical Affairs, THV_CT.gov@Edwards.com, 949-250-2500, Morristown Medical Center, Morristown, NJ, USA,Leiden University Medical Center, Leiden, The Netherlands,Cedars-Sinai Medical Center, Los Angeles, CA, USA, (ICTRP)
Sekundäre IDs
2021-01 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04889872 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar