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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04275726




Registration number
NCT04275726
Ethics application status
Date submitted
4/02/2020
Date registered
19/02/2020

Titles & IDs
Public title
LANDMARK Trial: a Randomised Controlled Trial of Myval THV
Scientific 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
Secondary ID [1] 0 0
2020-000137-40
Secondary ID [2] 0 0
MLS/MYV-2/LANDMARK
Universal Trial Number (UTN)
Trial acronym
LANDMARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Myval THV Series
Treatment: Devices - Contemporary Valves (Sapien THV Series and Evolut THV Series)

Experimental: Myval THV Series - 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.

Active comparator: Contemporary Valves - * 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.


Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Combined Safety and Effectiveness Endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)
Timepoint [1] 0 0
30-day
Secondary outcome [1] 0 0
The combined safety and effectiveness endpoint as defined by the Valve Academic Research Consortium-3 (VARC-3)
Timepoint [1] 0 0
1-year
Secondary outcome [2] 0 0
All-cause mortality
Timepoint [2] 0 0
Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4 year, 5-year, 7-year, and 10-year
Secondary outcome [3] 0 0
All stroke
Timepoint [3] 0 0
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Secondary outcome [4] 0 0
Acute Kidney Injury (AKI) (Stage 2, 3 and 4)
Timepoint [4] 0 0
Pre-discharge, 30-day, and 1-year
Secondary outcome [5] 0 0
Bleeding (Type 3 and 4)
Timepoint [5] 0 0
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Secondary outcome [6] 0 0
Moderate or severe prosthetic valve regurgitation
Timepoint [6] 0 0
Pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Secondary outcome [7] 0 0
New permanent pacemaker implantation (As per VARC-3 defined criteria)
Timepoint [7] 0 0
Pre-discharge, 30-day, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 7-year, and 10-year
Secondary outcome [8] 0 0
Conduction disturbances and arrhythmias
Timepoint [8] 0 0
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Secondary outcome [9] 0 0
Device success
Timepoint [9] 0 0
Pre-discharge and 30-day
Secondary outcome [10] 0 0
Early safety at 30 days
Timepoint [10] 0 0
30-day
Secondary outcome [11] 0 0
Clinical efficacy at 30 days
Timepoint [11] 0 0
After 30 days of index procedure
Secondary outcome [12] 0 0
Valve related long-term clinical efficacy
Timepoint [12] 0 0
5-years, 7 years and 10 years
Secondary outcome [13] 0 0
Vascular and access related complications
Timepoint [13] 0 0
Pre-discharge, 30-day, and 1-year
Secondary outcome [14] 0 0
Major vascular complications
Timepoint [14] 0 0
Pre-discharge, 30-day, and 1-year
Secondary outcome [15] 0 0
Functional improvement from baseline as measured per
Timepoint [15] 0 0
[Time frame: Baseline (pre-procedure), 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year], [Time frame: Baseline (pre-procedure), 30-day and 1-year]
Secondary outcome [16] 0 0
Echocardiographic endpoints
Timepoint [16] 0 0
Baseline, pre-discharge, 30-day, 1-year, 3-year, 5-year, 7-year, and 10-year
Secondary outcome [17] 0 0
Bioprosthetic valve deterioration
Timepoint [17] 0 0
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Secondary outcome [18] 0 0
Patient-prosthesis mismatch
Timepoint [18] 0 0
Pre-discharge, 30-day, and 1-year
Secondary outcome [19] 0 0
Length of index hospital stay
Timepoint [19] 0 0
At discharge
Secondary outcome [20] 0 0
Re-hospitalization
Timepoint [20] 0 0
30-day, 1-year, 3-year, and 5-year
Secondary outcome [21] 0 0
Health status as evaluated by Quality of Life questionnaires
Timepoint [21] 0 0
Baseline (pre-procedure), 30-day, and 1-year
Secondary outcome [22] 0 0
Valve thrombosis
Timepoint [22] 0 0
30-day, 1-year, 3-year, and 5-year
Secondary outcome [23] 0 0
Coronary obstruction requiring intervention
Timepoint [23] 0 0
Pre-discharge
Secondary outcome [24] 0 0
Valve malpositioning
Timepoint [24] 0 0
Pre-discharge
Secondary outcome [25] 0 0
Conversion to open surgery
Timepoint [25] 0 0
Pre-discharge
Secondary outcome [26] 0 0
Unplanned use of mechanical circulatory support (cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), transcatheter pumps or intra-aortic balloon pump (IABP)
Timepoint [26] 0 0
Pre-discharge
Secondary outcome [27] 0 0
Implantation of multiple (>1) transcatheter valves during the index hospitalization
Timepoint [27] 0 0
Index-procedure
Secondary outcome [28] 0 0
Cardiac structural complications
Timepoint [28] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary outcome [29] 0 0
Ventricular septal perforation
Timepoint [29] 0 0
Pre-discharge
Secondary outcome [30] 0 0
New onset of atrial fibrillation or atrial flutter
Timepoint [30] 0 0
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Secondary outcome [31] 0 0
Technical success
Timepoint [31] 0 0
Post-procedure
Secondary outcome [32] 0 0
Myocardial Infarction
Timepoint [32] 0 0
Pre-discharge, 30-day, 1-year, 3-year, and 5-year
Secondary outcome [33] 0 0
Endocarditis
Timepoint [33] 0 0
30-day, 1-year, 3-year, and 5-year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2033
Actual
Sample size
Target
768
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belarus
State/province [1] 0 0
Minsk
Country [2] 0 0
Brazil
State/province [2] 0 0
São Paulo
Country [3] 0 0
Croatia
State/province [3] 0 0
Split
Country [4] 0 0
Croatia
State/province [4] 0 0
Zagreb
Country [5] 0 0
Estonia
State/province [5] 0 0
Tallinn
Country [6] 0 0
France
State/province [6] 0 0
Créteil
Country [7] 0 0
France
State/province [7] 0 0
Lille
Country [8] 0 0
France
State/province [8] 0 0
Massy
Country [9] 0 0
France
State/province [9] 0 0
Nice
Country [10] 0 0
France
State/province [10] 0 0
Rennes
Country [11] 0 0
Germany
State/province [11] 0 0
Hesse
Country [12] 0 0
Germany
State/province [12] 0 0
Saxony
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Krozingen
Country [14] 0 0
Germany
State/province [14] 0 0
Braunschweig
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Regensburg
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Maroúsi
Country [20] 0 0
Greece
State/province [20] 0 0
Thessaloniki
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Italy
State/province [22] 0 0
Bologna
Country [23] 0 0
Italy
State/province [23] 0 0
Catania
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Milan
Country [26] 0 0
Italy
State/province [26] 0 0
Tortona
Country [27] 0 0
Italy
State/province [27] 0 0
Turin
Country [28] 0 0
Netherlands
State/province [28] 0 0
Dutch
Country [29] 0 0
Netherlands
State/province [29] 0 0
Gelderland
Country [30] 0 0
Netherlands
State/province [30] 0 0
Overijssel
Country [31] 0 0
Netherlands
State/province [31] 0 0
Amsterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Breda
Country [33] 0 0
Netherlands
State/province [33] 0 0
Groningen
Country [34] 0 0
Netherlands
State/province [34] 0 0
Utrecht
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
Poland
State/province [36] 0 0
Malopolskie Województwo
Country [37] 0 0
Poland
State/province [37] 0 0
Pomorskie Województwo
Country [38] 0 0
Poland
State/province [38] 0 0
Prussian
Country [39] 0 0
Poland
State/province [39] 0 0
Warsaw
Country [40] 0 0
Poland
State/province [40] 0 0
Wroclaw
Country [41] 0 0
Portugal
State/province [41] 0 0
Carnaxide
Country [42] 0 0
Portugal
State/province [42] 0 0
Lisboa
Country [43] 0 0
Portugal
State/province [43] 0 0
Lisbon
Country [44] 0 0
Portugal
State/province [44] 0 0
Porto
Country [45] 0 0
Slovakia
State/province [45] 0 0
Banská Bystrica
Country [46] 0 0
Slovenia
State/province [46] 0 0
Ljubljana
Country [47] 0 0
Spain
State/province [47] 0 0
Canary Islands
Country [48] 0 0
Spain
State/province [48] 0 0
Illes Balears
Country [49] 0 0
Spain
State/province [49] 0 0
Córdoba
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Valladolid
Country [52] 0 0
Sweden
State/province [52] 0 0
Göteborg
Country [53] 0 0
Sweden
State/province [53] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Meril Life Sciences Pvt. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Baumbach, MD,FESC,FRCP
Address 0 0
Barts Heart Center, London, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ashok Thakkar, PhD
Address 0 0
Country 0 0
Phone 0 0
+91-9879443584
Fax 0 0
Email 0 0
ashok.thakkar@merillife.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04275726