LANDMARK Trial is designed to compare safety and effectiveness of Meril*s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards* Sapien THV series and Medtronic*s Evolut THV series) in patients with severe symptomatic native…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/outcome of the study:
It is the composite of following (at 30 days) VARC-3 defined criteria:
- All-cause mortality
- All stroke
- Bleeding (Type 3 and 4)
- Acute kidney injury (stage 2, 3 and 4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new permanent pacemaker
implantation
Secondary outcome
1- It is the composite of following [at 1-year] (VARC-3 defined criteria):
- All-cause mortality
- All stroke
- Bleeding (Type 3 and 4)
- Acute kidney injury (stage 2, 3 and 4)
- Major vascular complications
- Moderate or severe prosthetic valve regurgitation
- Conduction system disturbances resulting in a new permanent pacemaker
implantation
2- All-cause mortality (VARC-3 defined criteria) (till 10-year)
3- All stroke (VARC-3 defined criteria till 5-year
4. Acute Kidney Injury (AKI)( stage 2, 3 and 4) (VARC-3 defined criteria) (
till 1-year)
5. Bleeding (Type 3 and 4) (VARC-3 defined criteria) (till 5-year)
6. Moderate or severe prosthetic valve regurgitation (VARC-3 defined criteria)
(10-year)
7. New permanent pacemaker implantation (VARC-3 defined criteria) (till 10-year)
8. Conduction disturbances and arrhythmias (VARC-3 defined criteria(till
5-year)
9. Technical success (VARC-3 defined criteria) [Time Frame: Post-procedure]
10 Device success (VARC-3 criteria)
11 Safety at 30 days (VARC-3 criteria)
12 Clinical efficacy at 30 days (VARC-2 criteria)
13. Valve related long-term clinical efficacy (VARC-3 defined criteria) (till
10 years)
14. Vascular and access related complications (VARC-3 defined criteria) (till
1-year)
15. Major vascular complications (VARC-3 defined criteria) (till 1-year)
16. Myocardial Infarction (VARC-3 defined criteria) (till 5-year)
17. Functional improvement from baseline as measured per
- NYHA class
- 6 minute walking test
18 - Echocardiographic parameters (till 10 years)
19- Bioprosthetic valve deterioration (VARC-3 defined criteria (5-year)
20. Patient-prosthesis mismatch (VARC-2 defined criteria) (till 1-year)
21 Days Length of index hospital stay
22 Re-hospitalization (VARC-3 defined criteria) (5-year)
23. Health status as evaluated by Quality of Life questionnaires
24. Valve thrombosis (VARC-2 defined criteria) (till 5-year)
25. Coronary obstruction requiring intervention (VARC-3 defined criteria)
26. Valve malpositioning (VARC-3 defined criteria
27. Conversion to open surgery (VARC-3 defined criteria)
28. Unplanned use of mechanical circulatory support (cardiopulmonary bypass
(CPB), extracorporeal membrane oxygenation (ECMO),
transcatheter pumps or intra-aortic balloon pump (IABP) (VARC-3 defined
criteria)
29. Implantation of multiple (>1) transcatheter valves during the index
hospitalization (VARC-3 defined criteria)
30. Cardiac structural complications (VARC-3 defined criteria) (till 5 years)
31. Ventricular septal perforation (VARC-2 defined criteria0
32. New onset of atrial fibrillation or atrial flutter (VARC-3 defined
criteria) (till5-year)
33. Endocarditis (VARC-3 defined criteria) (till 5-year]
Background summary
Aortic stenosis (AS) is one of the most prevalent diseases in the elderly
patient population (>65 years of age). The estimated prevalence of the disease
varies from 2% to 7% in the elderly population. The disease has a significant
impact on patient morbidity and mortality as well as healthcare expenditures.
Transcatheter aortic valve implantation (TAVI) has been introduced to treat
patients with severe symptomatic aortic stenosis
Study objective
LANDMARK Trial is designed to compare safety and effectiveness of Meril*s Myval
Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards* Sapien
THV series and Medtronic*s Evolut THV series) in patients with severe
symptomatic native aortic valve stenosis
Study design
This is a prospective, randomised, multinational, multicentric, open-label
non-inferiority trial to compare clinical outcomes of Myval THV Series vs.
Contemporary Valves in severe symptomatic native aortic valve stenosis patients
via transfemoral approach. The trial includes a total of 768 subjects across
the globe.
A non-randomised nested registry will be conducted to include patients
requiring extra-large size (30.5 mm and 32 mm) of Myval THV (XL Nested
Registry)
Intervention
1 group (384 patients) will be treated with the Myval transcatheter heartvalve.
1 group (384 patients) will be treated with the Edwards Sapien or Medtronic
Evolut heartvalve.
For the nested registry approximately 100 patients will be recruited from
approximately 30 participating centres in the LANDMARK trial.
Study burden and risks
Based on current experience we do not expect extra risks.
Bilakhia House, Survey 135/139
Chala Vapi Muktanand Marg
IN
Bilakhia House, Survey 135/139
Chala Vapi Muktanand Marg
IN
Listed location countries
Age
Inclusion criteria
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
Any condition, which in the Investigator*s opinion, would preclude safe
participation of
patient in the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | NCT0427526 ClinicalTrial.gov |
| CCMO | NL73302.100.20 |