Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3. The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29). Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM. Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).

Official Title
-----------------
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis

Conditions
-----------------
Aortic Valve Stenosis, Aortic Valve Regurgitation

Intervention / Treatment
-----------------
* Device: Sapien 3 Transcather Aortic Valve Implant
* Device: Myval Transcather Aortic Valve Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed with aortic stenosis (effective aortic<1.0 cm2) accepted for a TAVI procedure by the Heart Team. Implantation of Sapien-3 transfemoral valve or Myval transfemoral prosthesis. Availability of the variables selected for the matching process: Left ventricular ejection fraction, aortic annulus diameter and area, eccentricity index, and calcium score (all measured using computed tomography), body surface area, and body mass index. Availability of imaging studies at baseline and at discharge or 30-day follow up. Exclusion Criteria: Failure to comply with matching criteria. Failure to properly analyse images in the echo core-lab.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sapien 3<br>Patients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI | Device: Sapien 3 Transcather Aortic Valve Implant<br>* Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.<br>|
| Myval<br>Patients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI | Device: Myval Transcather Aortic Valve Implant<br>* Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean transvalvular gradients | Mean Gradients measured in doppler echography are calculated based on the mean velocity of the tracing. The velocities are converted to pressure gradients using the Bernoulli equation. | 30 days | 
| Aortic valve area | Echography measured Aortic valve area | 30 days | 
| Aortic valve perivalvular leak | Echography measured perivalvular leak | 30 days | 
| Aortic valve central leak | Echography measured central leak | 30 days | 
| Aortic valve global leak | Echography measured global leak | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality rate |  | 30 days | 
| All-cause mortality rate |  | 30 days | 
| Myocardial infarction rate |  | 30 days | 
| Bleeding complications rate |  | 30 days | 
| Acute kidney injury rate |  | 30 days | 
| Vascular complications rate |  | 30 days | 
| Conduction disorder rate |  | 30 days | 
| Re-hospitalization rate |  | 30 days | 
| Need for permanent pacemaker rate |  | 30 days | 
| New York Heart Association (NYHA) functional class |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAVI, TAVR, Balloon-Expandable transcatheter heart valve