| CTRI Number |
CTRI/2024/05/067405 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
safety and efficacy of Haemodynamx device for aortic
stenosis |
|
Scientific Title of Study
|
Safety and performance of a novel transcatheter treatment for symptomatic aortic
stenosis by aortic pressure recovery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TL-FIH-HEMO-2023-01; Version:1.1; Date:11/12/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Satish |
| Designation |
Senior lnterventional Cardiologist |
| Affiliation |
Apollo Hospital |
| Address |
Room Number 3, Ground floor, Department of Cardiology Apollo Hospital Off Greams Road Chennai-600006
Chennai
TAMIL NADU
Chennai
TAMIL NADU
600006
India |
| Phone |
9841277777 |
| Fax |
|
| Email |
doc@saisatish.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nancy Chugh |
| Designation |
Marketing Manager International Business & Clinical Initiatives |
| Affiliation |
Translumina Therapeutics LLP |
| Address |
Translumina Therapeutics LLP
Ground Floor Metro Tower Local Shopping Complex MOR Land
New Rajinder Nagar
Central DELHI
110060
India
Central
DELHI
110060
India |
| Phone |
9996235253 |
| Fax |
|
| Email |
drnancychugh@translumina.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brijesh Mishra |
| Designation |
Clinical Research Manager |
| Affiliation |
Translumina Therapeutics LLP |
| Address |
Translumina Therapeutics LLP
Ground Floor Metro Tower Local Shopping Complex MOR Land
New Rajinder Nagar
Central DELHI
110060
India
Central
DELHI
110060
India |
| Phone |
9654596737 |
| Fax |
|
| Email |
drbrijeshmishra@translumina.in |
|
|
Source of Monetary or Material Support
|
| Translumina Therapeutics LLP
Ground Floor, Metro Tower, Local Shopping Complex MOR Land, New Rajinder Nagar Central Delhi-110060 |
|
|
Primary Sponsor
|
| Name |
Translumina Therapeutics LLP |
| Address |
Ground Floor, Metro Tower, Local Shopping Complex MOR Land, New Rajinder Nagar Central Delhi-110060 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Sai Satish |
Apollo Hospital Chennai |
Room Number 3, Ground floor, Department of Cardiology
Apollo Hospital
Off Greams Road
Chennai-600006
Chennai
TAMIL NADU |
044-28296441
doc@saisatish.com |
| Dr Ashok Seth |
Fortis Escort, Okhla, Delhi |
CV Raman Road, Near Holy Family Hospital, Masih Garh, Okhla, Delhi 110025
South
DELHI |
9810025814
ashok.seth@fortishealthcare.com |
| Dr Rishi Sethi |
King George’s Medical University |
Administrative Block, Research Cell, Department of Cardiology, King George’s Medical University, Lucknow- 226003
Lucknow
UTTAR PRADESH |
9415085717
drrishisethi1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Clinical Studies Apollo Hospitals, Chennai |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
The Hemodynamx System |
The implant is to be implanted in the ascending aorta using a transcatheter
method, intended for decreasing the left ventricle workload in patients with
aortic stenosis.
The implant will be used during index procedure day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Assessment and approval by site investigator and sponsor assignee, that patient is eligible candidate for this treatment and study.
2. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by
the applicable Medical Ethics Committee (EC).
3. Greater than 18 years of age
4. Aortic sinotubular junction (STJ) diameter meets the range of 25 to 32 mm, as measured by CT (performed within the past 180 days).
5. Aortic brachiocephalic diameter meets the range of 27 to 35 mm, as measured by CT (performed within the past 180 days).
6. Patient has severe degenerative aortic stenosis with echocardiography derived mean gradient >40mmHg, and/or peak velocity greater than
4.0 m/s, and/or an initial valve area of <1.0 cm2
7.Patient has symptomatic aortic stenosis as demonstrated by NYHA of II or greater.
8. Patient is within the acceptable surgical risk aortic valve replacement, as assessed by the site investigator and sponsor assignee.
9. Patient has structurally normal cardiac anatomy.
10. Willing and able to comply with all required follow-up evaluation |
|
| ExclusionCriteria |
| Details |
1. Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 12 months.
2. Patient has carotid artery disease requiring intervention.
3. Patient has evidence of a myocardial infarction (MI) within the past 3 months.
4. Patient has hypertrophic cardiomyopathy, based on physician discretion.
5. Patient has a native aortic valve with an abnormal, or eccentric jet, as assessed by echo.
6. Patient has mitral or tricuspid valvular regurgitation of grade III or moderate mitral stenosis, as assessed by echo.
7. Patient has aortic regurgitation more than mild.
8. Patient has rheumatic heart disease
9. Patient had prior CABG operation with ascending aorta grafts.
10. Patient has a pre-existing prosthetic valve or prosthetic ring in any position.
11. Patient refuses blood transfusion or surgical valve replacement.
12. Patient has resting left ventricular ejection fraction (LVEF) less than 30%.
13. Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
14. Patient has severe basal septal hypertrophy, as asses by echo or CT.
15. Patient has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 90 days of the index procedure (does not apply to diagnostic angiography or angio-CT).
16. Patient has a history of or has active endocarditis.
17. Patient has echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation.
18. Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
19. Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
20. Patient with significant pulmonary disease
21. Patient has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
22. Patient has renal insufficiency as evidenced by a GFR less than 30 ml per min or end-stage renal disease requiring chronic dialysis.
23. Patient’s iliofemoral arteries have severe calcification, tortuosity more than two 90-degree bends, diameter more than 6mm, or subject has had an aorto femoral bypass that preclude safe placement of a 18 French sheath;
24. Patient has blood dyscrasia (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy).
25. Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
26. Patient with heavily calcified aorta.
27. Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the iliofemoral arteries.
28. Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure.
29. Patient has a life expectancy of less than 12 months.
30. Patient has other medical, social or psychological conditions that, in the opinion of the Principal Investigator, preclude the subject from study participation.
31. Patient has a known allergy to contrast media or nitinol alloys.
32. Patient has a history of any cognitive or mental health status that would interfere with study participation.
33. Pregnant or breastfeeding women.
34. Currently participating in another trial;
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
All-cause mortality
Hemodynamic improvement, demonstrated by reduction of the mean aortic pressure gradient by 35%, or effective orifice area
improvement of 25%, comparing baseline to 3-month post-procedure measured invasively by a right and left heart catheterization.
|
30 days
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Absence of Device, Investigational Procedure related Serious Adverse Events at 30 days including:
Major stroke, Myocardial infarction, Major vascular complication, Major Bleeding, Acute Kidney Injury stage II or III, Study implant deterioration requiring repeat procedure transcatheter or surgical valve replacement
Other device-related, or procedure-related SAEs |
1 year |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Hemodynamx System (the study device) is designed to treat patients with severe, degenerative aortic stenosis,
by increasing the aortic valve effective orifice area (EOA), thus reducing left ventricular (LV) pressure.
Advantages of the Hemodynamx System compared to SAVR or TAVR include:
Lower risk, by preserving the integrity of the heart without contact with the conduction system or native aortic
valve. This would eliminate the risk of a permanent pacemaker, paravalvular leak, or debris emboli from the native
valve. It would also support a psychological benefit of not having to replace the native valve.
The purpose of this First-in-Human (FIH) study is to test the Hemodynamx System in human subjects. The
Hemodynamx System is manufactured by Translumina Therapeutics LLP. and is designed to increase aortic valve
effective orifice area (EOA), thus reducing left ventricular (LV) pressure in patients with severe, degenerative aortic
stenosis. |