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LANDMARK Trial: a Randomised Controlled Trial of Myval THV (LANDMARK)

Primary Purpose

Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Myval THV Series
Contemporary Valves (Sapien THV Series and Evolut THV Series)
Sponsored by
Meril Life Sciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring LANDMARK Trial, Trial to evaluate safety & effectiveness of Myval THV, CE Approved Myval THV Series

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient ≥18 years of age.
  2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study.
  3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.

Exclusion Criteria:

  1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
  2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.

Sites / Locations

  • Republican Scientific-Practical Centre "Cardiology"
  • Hospital Dante PazanesseRecruiting
  • Split Clinical Hospital CenterRecruiting
  • University Hospital Dubrava Avenija Gojka Šuška 6Recruiting
  • North Estonia Medical CenterRecruiting
  • Hôpital Henri MondorRecruiting
  • Lille UniversityRecruiting
  • Institut Cardiovascular Paris-Sud
  • Arnault Tzanck InstituteRecruiting
  • Centre Hospitalier Universitaire De Rennes
  • Kerckhoff-KlinikForschungs GmbH
  • Leipzig Heart Institute GmbH
  • University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
  • Klinikum Braunschweig Freisestre
  • Technology University Dresden Fetscherstraße 76
  • Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
  • Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
  • Hippkration HospitalRecruiting
  • Interbalkan European Medical CenterRecruiting
  • Semmelweis UniversityRecruiting
  • University of Bologna Policlinico S. Orsola-Malpigh
  • Policlinico di Catania
  • San Raffaele HospitalRecruiting
  • Clinical Institute Saint Ambrogio Via Luigi Giuseppe Faravelli
  • San Donato HospitalRecruiting
  • Mauriliano Hospital Largo Filippo
  • University Hospital Città della Salute e della Scienza Turin Bramante
  • St Antonius HospitalRecruiting
  • Radboud University NijmegenRecruiting
  • Isala Zwolle Hospital
  • Onze lieve vrouwe gasthuis Oosterperk 9
  • Amphia Ziekenhui HospitalRecruiting
  • University Medical Center (UMC)
  • University Medical Center UtrechtRecruiting
  • Auckland City Hospital 2 Park RoadRecruiting
  • John Paul II Hospital
  • University of Gdansk
  • Medical University of Silesia
  • Institute of Cardiology
  • Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58Recruiting
  • Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos SantosRecruiting
  • Hospital de Santa Maria, Av. Prof. Egas Moniz MB
  • Centro Hospital Lisboa Central E.P.E. - Santa Marta
  • Centro Hospitalar de Sao Joao
  • University hospital Banska Bystrica Námestie Ludvíka Svobodu 1Recruiting
  • University Medical Center, LjubljanaRecruiting
  • Hospital Universitario de Gran Canaria Dr NegrinRecruiting
  • Hospital Universitari Son Espases Carretera de ValldemossaRecruiting
  • Hospital Universitario Renei SofiaRecruiting
  • Hospital Clínico San Carlos
  • Hospital Cliinico Univertistario de ValladolidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myval THV Series

Contemporary Valves

Arm Description

Myval THV Series will include Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.

Sapien THV Series will consist of Sapien 3/Sapien 3 Ultra THVs or any subsequent advanced version commercially available at the study site. Evolut THV Series will include Evolut R/Evolut PRO THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.

Outcomes

Primary Outcome Measures

Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-2 (VARC-2)
It is the composite of following: All-cause mortality All stroke Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3) Major vascular complications Moderate or severe prosthetic valve regurgitation Conduction system disturbances resulting in a new permanent pacemaker implantation.

Secondary Outcome Measures

The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-2 (VARC-2)
It is the composite of following: All-cause mortality All stroke Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3) Major vascular complications Moderate or severe prosthetic valve regurgitation Conduction system disturbances resulting in a new permanent pacemaker implantation.
All-cause mortality
As per VARC-2 criteria
All stroke (disabling and non-disabling)
Disabling stroke: an mRS score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline Non-disabling stroke: an mRS score of 2 at 90 days or one that does not result in an increase in at least one mRS category from an individual's pre-stroke baseline
Acute Kidney Injury (AKI)
Based on the Acute Kidney Injury Network (AKIN) System-Stage 2 or Stage 3 (including renal replacement therapy)
Life-threatening or disabling bleeding
As per VARC-2 criteria
Moderate or severe prosthetic valve regurgitation
As per VARC-2 criteria
New permanent pacemaker implantation
New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block.
Conduction disturbances and arrhythmias
As per VARC-2 criteria
Device success
As per VARC-2 criteria
Early safety at 30 days
As per VARC-2 criteria
Clinical efficacy at 30 days
As per VARC-2 criteria
Time-related valve safety
As per VARC-2 criteria
Vascular and access related complications
As per VARC-2 criteria
Major vascular complications
As per VARC-2 criteria
Functional improvement from baseline as measured per
New York Heart Association (NYHA) functional classification
Functional improvement from baseline as measured per
Six-minute walk test
Echocardiographic endpoints (1)
- Effective orifice area (EOA)
Echocardiographic endpoints (2)
- Index effective orifice area (iEOA)
Echocardiographic endpoints (3)
- Mean aortic valve gradient
Echocardiographic endpoints (4)
- Peak aortic valve gradient
Echocardiographic endpoints (5)
- Peak aortic velocity
Echocardiographic endpoints (6)
- Total aortic regurgitation, transvalvular regurgitation (except baseline) and paravalvular regurgitation (except baseline)
Echocardiographic endpoints (7)
- Left ventricular ejection fraction (LVEF)
Echocardiographic endpoints (8)
- Valve calcification
Echocardiographic endpoints (9)
- Cardiac output and cardiac index
Prosthetic valve dysfunction
VARC-2 criteria
Patient-prosthesis mismatch
Severity patient-prosthesis mismatch will be based on following For subjects with BMI <30 kg/m2, index effective orifice area (iEOA) 0.85 - 0.65 cm2 /m2 considered as moderate and <0.65 cm2 /m2 considered as severe For subjects with BMI ≥30 kg/m2, index effective orifice area (iEOA) 0.90 - 0.60 cm2 /m2 considered as moderate and <0.60 cm2 /m2 considered as severe BMI = weight(kg)/(height (m)) 2
Length of index hospital stay
• Number of days from index procedure to discharge
Hospitalization for valve-related symptoms or worsening congestive heart failure
NYHA class III or IV
Health status as evaluated by Quality of Life questionnaires
• SF-12
Valve thrombosis
Valve thrombosis as per VARC-2 is any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis
Coronary obstruction requiring intervention
Coronary obstruction requiring intervention
Valve malpositioning
As per VARC-2 criteria
Conversion to open surgery
Conversion to open surgery
Unplanned use of cardiopulmonary bypass (CPB)
Unplanned use of CPB for haemodynamic support at any time during the TAVI procedure
Ventricular septal perforation
Angiographic or echocardiographic evidence of a new septal perforation during or after the TAVI procedure
New onset of atrial fibrillation or atrial flutte
atrial fibrillation or atrial flutter
Endocarditis
Endocarditis
Major bleeding event
As per VARC-2 criteria

Full Information

First Posted
February 4, 2020
Last Updated
July 29, 2023
Sponsor
Meril Life Sciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04275726
Brief Title
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Acronym
LANDMARK
Official Title
A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meril Life Sciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)
Detailed Description
LANDMARK Trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach. Device sizes applicable for the Myval THV Series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter. Device sizes applicable for the Sapien 3 THV Series: 20 mm, 23 mm, 26 mm, and 29 mm diameter. Device sizes applicable for the Evolut THV Series: 23 mm, 26 mm, 29 mm, and 34 mm diameter. A non-randomised nested registry will be conducted to include patients requiring extra-large size of Myval THV series (XL Nested Registry) - Device sizes applicable for the XL Nested Registry: 30.5 mm and 32 mm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
LANDMARK Trial, Trial to evaluate safety & effectiveness of Myval THV, CE Approved Myval THV Series

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
768 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myval THV Series
Arm Type
Experimental
Arm Description
Myval THV Series will include Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.
Arm Title
Contemporary Valves
Arm Type
Active Comparator
Arm Description
Sapien THV Series will consist of Sapien 3/Sapien 3 Ultra THVs or any subsequent advanced version commercially available at the study site. Evolut THV Series will include Evolut R/Evolut PRO THVs or any subsequent advanced version commercially available at the study site. This treatment arm will be assigned to 384 / 768 subjects enrolled in a study.
Intervention Type
Device
Intervention Name(s)
Myval THV Series
Other Intervention Name(s)
Myval/Myval Inception THVs or any subsequent advanced version commercially available at the study site.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Contemporary Valves (Sapien THV Series and Evolut THV Series)
Other Intervention Name(s)
Sapien THV Series (Sapien 3/Sapien 3 Ultra THVs) and Evolut THV Series (Evolut R/Evolut PRO THVs ) or any subsequent advanced version commercially available at the study site.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-2 (VARC-2)
Description
It is the composite of following: All-cause mortality All stroke Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3) Major vascular complications Moderate or severe prosthetic valve regurgitation Conduction system disturbances resulting in a new permanent pacemaker implantation.
Time Frame
30-day
Secondary Outcome Measure Information:
Title
The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-2 (VARC-2)
Description
It is the composite of following: All-cause mortality All stroke Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3) Major vascular complications Moderate or severe prosthetic valve regurgitation Conduction system disturbances resulting in a new permanent pacemaker implantation.
Time Frame
1-year
Title
All-cause mortality
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 6-month, 1-year, 2-year, 3-year, 4 year, 5-year, 7-year, and 10-year
Title
All stroke (disabling and non-disabling)
Description
Disabling stroke: an mRS score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline Non-disabling stroke: an mRS score of 2 at 90 days or one that does not result in an increase in at least one mRS category from an individual's pre-stroke baseline
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, and 5-year
Title
Acute Kidney Injury (AKI)
Description
Based on the Acute Kidney Injury Network (AKIN) System-Stage 2 or Stage 3 (including renal replacement therapy)
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, and 1-year
Title
Life-threatening or disabling bleeding
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, and 5-year
Title
Moderate or severe prosthetic valve regurgitation
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
New permanent pacemaker implantation
Description
New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block.
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 7-year, and 10-year
Title
Conduction disturbances and arrhythmias
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, and 5-year
Title
Device success
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure) and 30-day
Title
Early safety at 30 days
Description
As per VARC-2 criteria
Time Frame
30-day
Title
Clinical efficacy at 30 days
Description
As per VARC-2 criteria
Time Frame
After 30 days of index procedure
Title
Time-related valve safety
Description
As per VARC-2 criteria
Time Frame
30-day, 1-year, 3-year and 5-year
Title
Vascular and access related complications
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, and 1-year
Title
Major vascular complications
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, and 1-year
Title
Functional improvement from baseline as measured per
Description
New York Heart Association (NYHA) functional classification
Time Frame
Baseline (within 30 days prior to index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year)
Title
Functional improvement from baseline as measured per
Description
Six-minute walk test
Time Frame
Baseline (within 30 days prior to index procedure), 30-day and 1-year
Title
Echocardiographic endpoints (1)
Description
- Effective orifice area (EOA)
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (2)
Description
- Index effective orifice area (iEOA)
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (3)
Description
- Mean aortic valve gradient
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (4)
Description
- Peak aortic valve gradient
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (5)
Description
- Peak aortic velocity
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (6)
Description
- Total aortic regurgitation, transvalvular regurgitation (except baseline) and paravalvular regurgitation (except baseline)
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (7)
Description
- Left ventricular ejection fraction (LVEF)
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (8)
Description
- Valve calcification
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Echocardiographic endpoints (9)
Description
- Cardiac output and cardiac index
Time Frame
Baseline (within 30 days prior to index procedure), pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Title
Prosthetic valve dysfunction
Description
VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, and 5-year
Title
Patient-prosthesis mismatch
Description
Severity patient-prosthesis mismatch will be based on following For subjects with BMI <30 kg/m2, index effective orifice area (iEOA) 0.85 - 0.65 cm2 /m2 considered as moderate and <0.65 cm2 /m2 considered as severe For subjects with BMI ≥30 kg/m2, index effective orifice area (iEOA) 0.90 - 0.60 cm2 /m2 considered as moderate and <0.60 cm2 /m2 considered as severe BMI = weight(kg)/(height (m)) 2
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, and 1-year
Title
Length of index hospital stay
Description
• Number of days from index procedure to discharge
Time Frame
Number of days from admission to discharge (expected average of 7 days)
Title
Hospitalization for valve-related symptoms or worsening congestive heart failure
Description
NYHA class III or IV
Time Frame
30-day, 1-year, 3-year, and 5-year
Title
Health status as evaluated by Quality of Life questionnaires
Description
• SF-12
Time Frame
Baseline (Within 30 days prior to index procedure), 30-day, and 1-year
Title
Valve thrombosis
Description
Valve thrombosis as per VARC-2 is any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis
Time Frame
30-day, 1-year, 3-year, and 5-year
Title
Coronary obstruction requiring intervention
Description
Coronary obstruction requiring intervention
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure)
Title
Valve malpositioning
Description
As per VARC-2 criteria
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure)
Title
Conversion to open surgery
Description
Conversion to open surgery
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure)
Title
Unplanned use of cardiopulmonary bypass (CPB)
Description
Unplanned use of CPB for haemodynamic support at any time during the TAVI procedure
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure)
Title
Ventricular septal perforation
Description
Angiographic or echocardiographic evidence of a new septal perforation during or after the TAVI procedure
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure)
Title
New onset of atrial fibrillation or atrial flutte
Description
atrial fibrillation or atrial flutter
Time Frame
Pre-discharge (within 24 hours prior to discharge or maximum of 7 days after index procedure), 30-day, 1-year, 3-year, and 5-year
Title
Endocarditis
Description
Endocarditis
Time Frame
30-day, 1-year, 3-year, and 5-year
Title
Major bleeding event
Description
As per VARC-2 criteria
Time Frame
30-day, 1-year, 3-year, and 5-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient ≥18 years of age. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices. Exclusion Criteria: Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashok Thakkar, PhD
Phone
+91-9879443584
Email
ashok.thakkar@merillife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Baumbach, MD,FESC,FRCP
Organizational Affiliation
Barts Heart Center, London, UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick W. Serruys, MD,PhD,FACC,FESC
Organizational Affiliation
National University of Ireland, Galway, Ireland
Official's Role
Study Director
Facility Information:
Facility Name
Republican Scientific-Practical Centre "Cardiology"
City
Minsk
ZIP/Postal Code
220036
Country
Belarus
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Oleg Polonetsky, MD, PhD
Email
polonetsky@yandex.ru
Facility Name
Hospital Dante Pazanesse
City
São Paulo
ZIP/Postal Code
04012-909
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Fausto Feres
Email
fferes@dantepazzanese.org.br
First Name & Middle Initial & Last Name & Degree
Andrea Vilela,
First Name & Middle Initial & Last Name & Degree
Dimytri Siqueira
Facility Name
Split Clinical Hospital Center
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ivica Kristic, MD, PhD
Email
kristicivica@gmail.com
Facility Name
University Hospital Dubrava Avenija Gojka Šuška 6
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Daniel Unić, MD
Phone
+385989196621
Email
unic@kbd.hr
Facility Name
North Estonia Medical Center
City
Tallinn
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Peep Laanmets
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Emmanuel Teiger
Email
emmanuel.teiger@aphp.fr
Facility Name
Lille University
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Eric Van Belle
Email
ericvanbelle@aol.com
Facility Name
Institut Cardiovascular Paris-Sud
City
Massy
ZIP/Postal Code
91300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Bernard Chevalier
Email
bchevali@aol.com
Facility Name
Arnault Tzanck Institute
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. ADJEDJ Julien
Email
juliendjdj@gmail.com
Facility Name
Centre Hospitalier Universitaire De Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vincent Auffret
Email
vincent.auffret@chu-rennes.fr
Facility Name
Kerckhoff-KlinikForschungs GmbH
City
Bad Nauheim
State/Province
Hesse
ZIP/Postal Code
61231
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Won K Kim, M.D
Phone
+49 60326152
Email
w.kim@kerckhoff-klinik.de
Facility Name
Leipzig Heart Institute GmbH
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Mohamed A Wahab, Ph. D
Phone
+493418650
Email
mohamed.abdel-wahab@medizin.uni-leipzig.de
Facility Name
University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Franz-Josef Neumann, MD
Phone
.+49 76334022000
Email
Franz-Josef.Neumann@universitaets-herzzentrum.de
Facility Name
Klinikum Braunschweig Freisestre
City
Braunschweig
ZIP/Postal Code
38118
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ingo Breitenbach
Email
i.breitenbach@skbs.de
Facility Name
Technology University Dresden Fetscherstraße 76
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Axel Linke
Email
Axel.Linke@herzzentrum-dresden.com
Facility Name
Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Samer Hakmi, MD
Email
samer@hakmi.des.hakmi@asklepois.com
Facility Name
Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Hippkration Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Konstantinos Toutouzas
Phone
+30 2132088026
Email
ktoutouz@gmail.com
Facility Name
Interbalkan European Medical Center
City
Thessaloníki
ZIP/Postal Code
555 35
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vlasis Ninios, MD, MRCP
Phone
+302310400929, +306948596047
Email
vninios@gmail.com
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Bela Merkely, MD Ph. D
Phone
36206632488
Email
merkely.bela@kardio.sote.hu
First Name & Middle Initial & Last Name & Degree
Dr. Roland Papp, MD
Facility Name
University of Bologna Policlinico S. Orsola-Malpigh
City
Bologna
ZIP/Postal Code
40141
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Francesco Saia
Email
francescosaia@hotmail.com
Facility Name
Policlinico di Catania
City
Catania
ZIP/Postal Code
95100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Corrado Tamburino
Email
tambucor@unict.it
Facility Name
San Raffaele Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Matteo Montorfano
Phone
+39 02 26437331
Email
montorfano.matteo@hsr.it
First Name & Middle Initial & Last Name & Degree
Dr.BELLINI BARBARA
Facility Name
Clinical Institute Saint Ambrogio Via Luigi Giuseppe Faravelli
City
Milano
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Alfonso Ielasi
Phone
+39 338 8433189
Email
alielasi@hotmail.com
Facility Name
San Donato Hospital
City
Milan
ZIP/Postal Code
20121-20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Francesco Bedogni
Phone
+ 39 335 5309117
Email
Francesco.bedogni@grupposandonato.it
Facility Name
Mauriliano Hospital Largo Filippo
City
Tortona
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Giuseppe Musumeci
Facility Name
University Hospital Città della Salute e della Scienza Turin Bramante
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Gaetano Maria De Ferrari
Phone
011 6334634
Email
gaetanomaria.deferrari@unito.it
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Dutch
ZIP/Postal Code
3435
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. B.J.W.M Rensing, Cardiologist
Phone
+31 306093974
Email
b.rensing@antoniusziekenhuis.nl
Facility Name
Radboud University Nijmegen
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 XZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Niels V Royen, Ph.D
Email
niels.vanroyen@radboudumc.nl
Facility Name
Isala Zwolle Hospital
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Onze lieve vrouwe gasthuis Oosterperk 9
City
Amsterdam
ZIP/Postal Code
1091
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Amphia Ziekenhui Hospital
City
Breda
ZIP/Postal Code
4817
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. A.J.J. Ijsselmuiden Sander
Phone
+31(0)655814502
Email
sander.ijsselmuiden@gmail.com
Facility Name
University Medical Center (UMC)
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Joanna J Wykrzykowska
Phone
+31-630367425
Email
joannawykrzykowska70@gmail.com/ j.wykrzykowska@amsterdamumc.nl
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Michiel Voskuil
Email
mvoskuil@umcutrecht.nl
Facility Name
Auckland City Hospital 2 Park Road
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Mark Webster, MD
Phone
+64 9 307 4949
Email
mwebster@adhb.govt.nz
Facility Name
John Paul II Hospital
City
Krakow
State/Province
Małopolskie Województwo
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr n. med Jaroslaw Trebacz, MD PhD
Facility Name
University of Gdansk
City
Gdańsk
State/Province
Pomorskie Województwo
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Medical University of Silesia
City
Katowice
State/Province
Prussian
ZIP/Postal Code
40-635
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Wojciech Wojakowski, MD PhD
Email
wwojakowski@sum.edu.pl
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
50-013
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Adam Witkowski, MD, PhD, FESC
Phone
+48 22 812 41 64
Email
witkowski@hbz.pl
Facility Name
Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58
City
Wrocław
ZIP/Postal Code
50-369
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Marcin Protasiewicz
Phone
+48 71 7364200
Email
marcin.protasiewicz@umed.wwroc.pl
Facility Name
Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Manuel Almeida
Phone
+351 936359285
Email
almeidams@sapo.pt
Facility Name
Hospital de Santa Maria, Av. Prof. Egas Moniz MB
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Pedro Carrilho Ferreira
Phone
+351 966 412 473
Email
pcarrilhoferreira@gmail.com
Facility Name
Centro Hospital Lisboa Central E.P.E. - Santa Marta
City
Lisbon
ZIP/Postal Code
1169-024
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Duarte Cacela
Email
dcacela@hotmail.com
Facility Name
Centro Hospitalar de Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Joao Carlos Silva, PhD
Email
joaocebsilva@hotmail.com
Facility Name
University hospital Banska Bystrica Námestie Ludvíka Svobodu 1
City
Banská Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Martin Hudec
Phone
+421 918 106033
Email
hudecmt@hotmail.com
Facility Name
University Medical Center, Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Matjaz Bunc, MD, PhD
Phone
+38615225050
Email
matjaz.bunc@kclj.si
Facility Name
Hospital Universitario de Gran Canaria Dr Negrin
City
Las Palmas
State/Province
Canary Islands
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Pedro Martin Lorenzo
Phone
+34928450000
Email
pemarlor@hotmail.com
Facility Name
Hospital Universitari Son Espases Carretera de Valldemossa
City
Palma De Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Vicente Peral
Phone
+34 871205381
Email
vicente.peral@ssib.es
First Name & Middle Initial & Last Name & Degree
Dr. Tania Rdgz Gabella
Facility Name
Hospital Universitario Renei Sofia
City
Córdoba
ZIP/Postal Code
5000
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Manuel Pan
Email
manuelpanalvarez@gmail.com
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Luis Nombela, MD, PhD
Phone
+34629510139
Email
luisnombela@yahoo.com
Facility Name
Hospital Cliinico Univertistario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ignacio A Santos, Medicine & Surgery
Phone
+34657923040
Email
ijamat@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Juan Pablo Sánchez Luna, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33160946
Citation
Kawashima H, Soliman O, Wang R, Ono M, Hara H, Gao C, Zeller E, Thakkar A, Tamburino C, Bedogni F, Neumann FJ, Thiele H, Abdel-Wahab M, Morice MC, Webster M, Rosseel L, Mylotte D, Onuma Y, Wijns W, Baumbach A, Serruys PW. Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial. Am Heart J. 2021 Feb;232:23-38. doi: 10.1016/j.ahj.2020.11.001. Epub 2020 Nov 6.
Results Reference
background
PubMed Identifier
33833944
Citation
Kawashima H, Wang R, Mylotte D, Jagielak D, De Marco F, Ielasi A, Onuma Y, den Heijer P, Terkelsen CJ, Wijns W, Serruys PW, Soliman O. Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves. Glob Heart. 2021 Mar 19;16(1):20. doi: 10.5334/gh.959.
Results Reference
derived
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/33160946/
Description
Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial

Learn more about this trial

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

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