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Not yet recruiting Not applicable NCT07532317

To Evaluate Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series Compared toGuideline-Directed Medical Therapy (GDMT) in Participants With Moderate Aortic Stenosis.

No applicable phase (e.g. observational)
Conditions: Moderate Aortic Valve Stenosis

Sponsor: Meril Life Sciences Pvt. Ltd.

trial.available_in: БГ
Overview
The primary objective of this trial is to evaluate the safety and effectiveness of Meril's Myval THV series in comparison to Guideline-Directed Medical Therapy in participants with moderate aortic stenosis. The trial includes a total of 778 participants (389:389) from approximately 50 investigator sites globally.
Description
Participants with symptomatic moderate aortic stenosis OR asymptomatic moderate aortic stenosis with evidence of cardiac damage as assessed by echocardiography core lab. Note: The detailed definitions and criterias for moderate AS are provided in inclusion criteria. Clinical and echocardiographic follow-up at: Pre-discharge \[Prior to hospital discharge (within 24 hours of the date of discharge) or maximum of 7 days after index procedure, whichever occurs earlier\] \[Applicable for the TAVI arm only\] 30-day (+ 7 days) \[Applicable for the TAVI arm only\] 6-month (+ 15 days) 1-year (+ 30 days) 1.5-year (+ 30 days) 2-year (+ 30 days) 2.5-year (+ 30 days) 3-year (+ 30 days) 5-year (+ 30 days) 10-year (+ 30 days) Telephonic follow-up at: 4-year (+ 30 days) 6-year (+ 30 days) 7-year (+ 30 days) Note: For participants randomized to the GDMT arm who subsequently undergo AVR or any other intervention at the investigator's discretion, a follow-up visit will be performed at 30 days after the procedure, with an additional follow-up at 1 year (recommended). Thereafter, participants will continue with the remaining scheduled study follow-up visits as per their original study timeline.
Who can participate
Inclusion Criteria: All participants for this study must meet all of the following inclusion criteria: 1. Participants with ≥ 65 years of age. 2. Participant has provided written informed consent as approved Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Ethics Committee (EC) of the investigational site to participate in the study. 3. Participant with moderate aortic stenosis, defined as one of the following(10) * Peak aortic jet velocity (Vmax) ≥ 3.0 m/s and \< 4.0 m/s, or * Mean pressure gradient ≥ 25 mmHg and \< 40 mmHg AND The participant must meet one of the following categories: 1.1.AVA \> 1.0 - ≤ 1.5 cm²; OR 1.2.AVA ≤ 1.0 cm2 (or AVAi ≤ 0.6 cm2/m2) 3.2.1 Left Ventricular Function and Flow Profile: It is defined as participants with peak aortic jet velocity (Vmax) ≥ 3.0 and \< 4.0 m/s or mean pressure gradient ≥ 25 and \< 40 mmHg, and in the presence of aortic valve area (AVA) ≤ 1.0 cm² (or AVAi ≤ 0.6 cm²/m²) The participant must meet one of the following categories: a.Normal-Flow, Preserved LVEF:\* * Stroke Volume Index (SVi \> 35 ml/m²) and LVEF ≥ 50% then, perform CT aortic valve calcium score to confirm true moderate AS: \< 1200 AU (female) or \< 2000 AU (male) OR b.Low-Flow, Preserved LVEF: * SVi ≤ 35 ml/m² and LVEF ≥ 50%, then perform CT aortic valve calcium score to confirm true moderate AS: \< 1200 AU (female) or \< 2000 AU (male) OR c.Low-Flow, Reduced LVEF: * SVi ≤ 35 ml/m² and LVEF \< 50%, then confirm contractile reserve on dobutamine stress echocardiography (DSE)\^, defined as a ≥ 20% increase in stroke volume with; I.AVA \> 1.0 and ≤ 1.5 cm2 or II.AVA \> 1.0 cm2 then perform CT aortic valve calcium score to confirm true moderate AS: \< 1200 AU (female) or \< 2000 AU (male) \^ If DSE is not feasible or inconclusive, CT calcium scoring will be considered, with thresholds of \< 1200 AU for female and \< 2000 AU for male to identify Moderate AS participants. \*Not applicable for asymptomatic participants as asymptomatic with SVi \> 35 are excluded. 4. Moderate AS participants with symptoms: 1. Evidence of symptoms: I.NYHA class ≥ II# and II.Chronic Dyspnea or III.Angina (CCS ≥ II) or IV.Cardiac Syncope OR 2. Asymptomatic moderate AS participants with at least one of the evidence of cardiac damage/dysfunction: I.Participant with left ventricle ejection fraction ≤ 50% or II.Diastolic dysfunction ≥ Grade II or III.Stroke Volume Index ≤ 35 ml/m² or IV.Persistent Atrial Fibrillation (AF) lasting from past 6 months or Paroxysmal Atrial Fibrillation episode within 6 months prior to consent or V.NT-proBNP ≥ 200 pg/ml or ng/l or ≥ 200000 µg/l (or BNP ≥ 50 pg/ml or ng/l or ≥ 50000 µg/l) or VI.LV mass index \> 95 g/m² for female and \> 115 g/m² for male (To detect LV hypertrophy)(15) or VII.LV dimension(16) or <!-- --> 1. LV systolic diameter \> 4 cm or \> 40 mm for male and \> 3.5 cm or 35 mm for female or 2. LV diastolic diameter \> 5.8 cm or \> 58 mm for male and \> 5.2 cm or 52 mm for female VIII.LV volume(16) <!-- --> 1. LV systolic volume \> 61 mL or cm3 for male and \> 42 mL or cm3 for female or 2. LV diastolic volume \> 150 mL or cm3 for male and \> 106 mL or cm3 for female #Only 10% of total study participants with NYHA class IV will be included in the trial. Exclusion Criteria: 1. Participants with moderate aortic stenosis undergoing concomitant CABG or surgical intervention on the ascending aorta or another valve. 2. Aortic valve is unicuspid or non-calcified as verified by echocardiography/CT. 3. Renal insufficiency with glomerular filtration rate (GFR) \< 30 mL/min and/or need for renal replacement therapy. 4. Participants with ≥ moderate concomitant aortic regurgitation (≥ 3 grade). 5. Participants with severe aortic stenosis. 6. Moderate or severe mitral/tricuspid regurgitation (≥ 3 grade). 7. Participants with pre-existing mechanical or bioprosthetic aortic valve. 8. Left ventricle ejection fraction ≤ 20%. 9. Severe left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVI. 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation. 11. Previous stroke with permanent disability (modified Rankin score ≥ 2). 12. Life expectancy \< 24 months due to non-cardiac co-morbid conditions including carcinomas, chronic liver disease, chronic renal disease or chronic end-stage pulmonary disease. 13. Currently participating in an investigational drug or another device study where the primary endpoint is not achieved. 14. Any condition, which in the Investigator's opinion, would preclude safe participation of participants in the study (e.g. psychiatric, alcoholism). 15. TAVI unsuitable via transfemoral route.
Interventions
Transcatheter aortic valve replacement
DEVICE
Locations 62
Australia (3)
Prince Charles Hospital
Brisbane , Queensland
Dr.Darren Walters, MBBS,MPhil,FRACP,FCSANZ,FSCAI
Victorian Heart Hospital
Melbourne , Victoria
John Hunter Hospital
Newcastle , New South Wales
Dr.Rohan Bhagwandeen, MBChB, FRACP
Belarus (1)
Republican Scientific and Practical Center of Cardiology (RSPC Cardiology)
Minsk , Minsk Oblast
Brazil (1)
Instituto Dante Pazzanese de Cardiologia
São Paulo , São Paulo
Denmark (2)
Rigshospitalet
Copenhagen , Capital Region
Rigshospitalet, Copenhagen University Hospital
Copenhagen , Capital Region of Denmark (Hovedstaden)
Estonia (1)
North Estonia Medical Centre (Põhja-Eesti Regionaalhaigla)
Tallinn , Harju
Finland (2)
Turku University Hospital (Tyks), Heart Centre
Turku , Southwest Finland
Turku University Hospital
Turku , Southwest Finland
France (13)
Centre Hospitalier Universitaire de Bordeaux
Bordeaux , New Aquitaine
Hôpital Henri-Mondor - Assistance Publique Hôpitaux de Paris
Créteil , Île-de-France Region
Centre Hospitalier Régional Universitaire de Lille
Lille , Hauts-de-France
Hôpital de la Timone - Assistance Publique Hôpitaux de Marseille
Marseille , Provence-Alpes-Côte d'Azur Region
Hôpital Privé Jacques Cartier (ICPS - Institut Cardiovasculaire Paris Sud)
Massy , Essonne
Centre Hospitalier Universitaire de Rennes
Rennes , Brittany Region
Centre Cardiologique du Nord
Saint-Denis , Île-de-France Region
Institut Arnault Tzanck
Saint-Laurent-du-Var , Provence-Alpes-Côte d'Azur Region
Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg
Strasbourg , Grand Est
Clinique Pasteur - Toulouse
Toulouse , Haute-Garonne
Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
Toulouse , Occitanie
Centre Hospitalier Universitaire de Tours
Tours , Centre-Val de Loire
Médipôle Lyon-Villeurbanne
Villeurbanne , Auvergne-Rhône-Alpes
Germany (6)
Kerckhoff Klinik GmbH
Bad Nauheim , Hesse
Städtisches Klinikum Braunschweig
Braunschweig , Lower Saxony
Herzzentrum Dresden GmbH Universitätsklinik
Dresden , Saxony
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau , Baden-Wurttemberg
Universitätsklinikum Leipzig
Leipzig , Saxony
Universitätsklinikum Regensburg
Regensburg , Bavaria
Italy (3)
IRCCS Ospedale San Raffaele
Milan , Milan
IRCCS Ospedale Galeazzi - Sant'Ambrogio
Milan , Milan
IRCCS Policlinico San Donato
San Donato Milanese , Milan
Netherlands (7)
OLVG
Amsterdam , North Holland
Giovanni Amoroso, MD
Amphia Hospital
Breda , North Brabant
Catharina Hospital
Eindhoven , North Brabant
Pim Tonino, MD
St. Antonius Hospital
Nieuwegein , Utrecht
Radboud University Medical Center
Nijmegen , Gelderland
Erasmus Medical Center
Rotterdam , South Holland
University Medical Center Utrecht
Utrecht , Utrecht
New Zealand (2)
Auckland City Hospital
Auckland , Auckland
Waikato Hospital
Hamilton , Waikato Region
North Macedonia (1)
University Clinic of Cardiology Skopje
Skopje , Grad Skopje
Norway (1)
Oslo University Hospital - Rikshospitalet
Oslo , Oslo
Slovakia (1)
Middle Slovak Institute of Cardiovascular Diseases (SÚSCCH)
Banská Bystrica , Banská Bystrica Region
Slovenia (1)
University Medical Centre Ljubljana
Ljubljana , Osrednjeslovenska
South Africa (1)
Netcare Sunninghill Hospital
Sandton , Gauteng
Spain (13)
Hospital Clínic de Barcelona
Barcelona , Catalonia
Hospital Universitario Reina Sofía
Córdoba , Córdoba
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria , Las Palmas
Hospital General Universitario Gregorio Marañón
Madrid , Madrid
Hospital Universitario Ramón y Cajal
Madrid , Madrid
Hospital Universitario La Paz
Madrid , Madrid
Hospital Universitario Son Espases
Palma de Mallorca , Balearic Islands
Hospital Clínico Universitario de Salamanca
Salamanca , Castille and León
Hospital Universitario Virgen del Rocío
Seville , Andalusia
Hospital Universitari i Politècnic La Fe
Valencia , Valencia
Hospital Clínico Universitario de Valladolid
Valladolid , Castille and León
Ignacio J. Amat-Santos, MD, PhD
Hospital Álvaro Cunqueiro
Vigo , Galicia
Hospital Universitario Miguel Servet
Zaragoza , Aragon
Sweden (1)
Uppsala University Hospital
Uppsala , Uppsala County
Switzerland (1)
Universitätsspital Basel
Basel , Canton of Basel-City
United Kingdom (1)
Barts Heart Centre, St Bartholomew's Hospital
London , England
Andreas Baumbach, MD
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
65 Years
Healthy volunteers
No
Start date
17.05.2026
Completion date
12.05.2038
Registry ID
NCT07532317
Source
clinicaltrials.gov
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