safety and efficacy of Haemodynamx device for aortic stenosis

Phase 1/2

Not yet recruiting

Conditions: Nonrheumatic aortic (valve) stenosis,

Registration Number: CTRI/2024/05/067405

Lead Sponsor: Translumina Therapeutics LLP

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1.Assessment and approval by site investigator and sponsor assignee, that patient is eligible candidate for this treatment and study.
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).
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).
Aortic brachiocephalic diameter meets the range of 27 to 35 mm, as measured by CT (performed within the past 180 days).
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.
Patient is within the acceptable surgical risk aortic valve replacement, as assessed by the site investigator and sponsor assignee.
Patient has structurally normal cardiac anatomy.
Willing and able to comply with all required follow-up evaluation.

Exclusion Criteria

Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 12 months.
Patient has carotid artery disease requiring intervention.
Patient has evidence of a myocardial infarction (MI) within the past 3 months.
Patient has hypertrophic cardiomyopathy, based on physician discretion.
Patient has a native aortic valve with an abnormal, or eccentric jet, as assessed by echo.
Patient has mitral or tricuspid valvular regurgitation of grade III or moderate mitral stenosis, as assessed by echo.
Patient has aortic regurgitation more than mild.
Patient has rheumatic heart disease 9.
Patient had prior CABG operation with ascending aorta grafts.
Patient has a pre-existing prosthetic valve or prosthetic ring in any position.
Patient refuses blood transfusion or surgical valve replacement.
Patient has resting left ventricular ejection fraction (LVEF) less than 30%.
Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
Patient has severe basal septal hypertrophy, as asses by echo or CT.
Patient has had a percutaneous interventional or other invasive cardiac or peripheral procedure â‰¤ 90 days of the index procedure (does not apply to diagnostic angiography or angio-CT).
Patient has a history of or has active endocarditis.
Patient has echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation.
Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
Patient with significant pulmonary disease 21.
Patient has renal insufficiency as evidenced by a GFR less than 30 ml per min or end-stage renal disease requiring chronic dialysis.
Patientâ€™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).
Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
Patient with heavily calcified aorta.
Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the iliofemoral arteries.
Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure.
Patient has a life expectancy of less than 12 months.
Patient has other medical, social or psychological conditions that, in the opinion of the Principal Investigator, preclude the subject from study participation.
Patient has a history of any cognitive or mental health status that would interfere with study participation.
Pregnant or breastfeeding women.
Currently participating in another trial;.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 days \| 3 months
Hemodynamic improvement, demonstrated by reduction of the mean aortic pressure gradient by 35%, or effective orifice area	30 days \| 3 months
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Apollo Hospital Chennai
🇮🇳
Chennai, TAMIL NADU, India
Apollo Hospital Chennai
🇮🇳Chennai, TAMIL NADU, India
Prof Sai Satish
Principal investigator
044-28296441
doc@saisatish.com