LANDMARK Trial: a Randomised Controlled Trial of Myval THV

NARecruitingINTERVENTIONAL
Enrollment

988

Participants

Timeline

Start Date

November 4, 2020

Primary Completion Date

March 7, 2024

Study Completion Date

December 31, 2033

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

Myval THV Series

The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.

DEVICE

Contemporary Valves (Sapien THV Series and Evolut THV Series)

The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.

Trial Locations (54)

1000

RECRUITING

University Medical Center, Ljubljana, Ljubljana

1023

RECRUITING

Auckland City Hospital 2 Park Road, Grafton

1091

ACTIVE_NOT_RECRUITING

Onze lieve vrouwe gasthuis Oosterperk 9, Amsterdam

1122

RECRUITING

Semmelweis University, Budapest

3435

RECRUITING

St Antonius Hospital, Nieuwegein

3584

RECRUITING

University Medical Center Utrecht, Utrecht

4817

RECRUITING

Amphia Ziekenhui Hospital, Breda

5000

RECRUITING

Hospital Universitario Renei Sofia, Córdoba

9713

NOT_YET_RECRUITING

University Medical Center (UMC), Groningen

10000

RECRUITING

University Hospital Dubrava Avenija Gojka Šuška 6, Zagreb

10126

NOT_YET_RECRUITING

University Hospital Città della Salute e della Scienza Turin Bramante, Turin

10128

NOT_YET_RECRUITING

Mauriliano Hospital Largo Filippo, Tortona

11527

RECRUITING

Hippkration Hospital, Athens

20099

NOT_YET_RECRUITING

Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5, Hamburg

20132

RECRUITING

San Raffaele Hospital, Milan

20149

RECRUITING

Clinical Institute Saint Ambrogio, Milan

21000

RECRUITING

Split Clinical Hospital Center, Split

28040

NOT_YET_RECRUITING

Hospital Clínico San Carlos, Madrid

35010

RECRUITING

Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas

35033

NOT_YET_RECRUITING

Centre Hospitalier Universitaire De Rennes, Rennes

38118

ACTIVE_NOT_RECRUITING

Klinikum Braunschweig Freisestre, Braunschweig

40141

NOT_YET_RECRUITING

University of Bologna Policlinico S. Orsola-Malpigh, Bologna

47003

RECRUITING

Hospital Cliinico Univertistario de Valladolid, Valladolid

59000

RECRUITING

Lille University, Lille

61231

RECRUITING

Kerckhoff-KlinikForschungs GmbH, Bad Nauheim

79189

RECRUITING

University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15, Bad Krozingen

91300

RECRUITING

Institut Cardiovascular Paris-Sud, Massy

93053

RECRUITING

Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg, Regensburg

94000

RECRUITING

Hôpital Henri Mondor, Créteil

95100

NOT_YET_RECRUITING

Policlinico di Catania, Catania

220036

NOT_YET_RECRUITING

"Republican Scientific-Practical Centre Cardiology", Minsk

04012-909

RECRUITING

Hospital Dante Pazanesse, São Paulo

Unknown

RECRUITING

North Estonia Medical Center, Tallinn

RECRUITING

Hygeia hospital, Marousi

RECRUITING

Sahlgrenska University Hospital, Gothenburg

RECRUITING

Uppsala University Hospital, Uppsala

06200

RECRUITING

Arnault Tzanck Institute, Nice

04289

RECRUITING

Leipzig Heart Institute GmbH, Leipzig

01307

RECRUITING

Technology University Dresden Fetscherstraße 76, Dresden

555 35

RECRUITING

Interbalkan European Medical Center, Thessaloniki

20121-20162

RECRUITING

San Donato Hospital, Milan

6525 XZ

RECRUITING

Radboud University Nijmegen, Nijmegen

8025 AB

ACTIVE_NOT_RECRUITING

Isala Zwolle Hospital, Zwolle

31-202

NOT_YET_RECRUITING

John Paul II Hospital, Krakow

80-952

NOT_YET_RECRUITING

University of Gdansk, Gdansk

40-635

NOT_YET_RECRUITING

Medical University of Silesia, Katowice

50-013

NOT_YET_RECRUITING

Institute of Cardiology, Warsaw

50-369

RECRUITING

Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58, Wroclaw

2790-134

RECRUITING

Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos, Carnaxide

1169-024

RECRUITING

Centro Hospital Lisboa Central E.P.E. - Santa Marta, Lisbon

1649-028

NOT_YET_RECRUITING

Hospital de Santa Maria, Av. Prof. Egas Moniz MB, Lisbon

4200-319

NOT_YET_RECRUITING

Centro Hospitalar de Sao Joao, Porto

975 17

RECRUITING

University hospital Banska Bystrica Námestie Ludvíka Svobodu 1, Banská Bystrica

07120

RECRUITING

Hospital Universitari Son Espases Carretera de Valldemossa, Palma de Mallorca

Sponsors
All Listed Sponsors
lead

Meril Life Sciences Pvt. Ltd.

INDUSTRY

NCT04275726 - LANDMARK Trial: a Randomised Controlled Trial of Myval THV | Biotech Hunter | Biotech Hunter