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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

416 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Aortic Valve Stenosis Aortic Valve Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sapien 3

Patients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI

Sapien 3 Transcather Aortic Valve Implant

Intervention Type DEVICE

Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.

Myval

Patients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI

Myval Transcather Aortic Valve Implant

Intervention Type DEVICE

Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.

Interventions

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Sapien 3 Transcather Aortic Valve Implant

Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.

Intervention Type DEVICE

Myval Transcather Aortic Valve Implant

Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.

Intervention Type DEVICE

Eligibility Criteria

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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.