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

Completed

• Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation
• Interventions: Device: Myval Transcather Aortic Valve Implant; Device: Sapien 3 Transcather Aortic Valve Implant

• Registration Number: NCT04548726
• Lead Sponsor: Ignacio J. Amat Santos

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-14
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myval	Myval Transcather Aortic Valve Implant	Patients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI
Sapien 3	Sapien 3 Transcather Aortic Valve Implant	Patients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI

Primary Outcome Measures

Name	Time	Method
Aortic valve central leak	30 days	Echography measured central leak
Mean transvalvular gradients	30 days	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.
Aortic valve area	30 days	Echography measured Aortic valve area
Aortic valve perivalvular leak	30 days	Echography measured perivalvular leak
Aortic valve global leak	30 days	Echography measured global leak

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Policlinico Umberto I; 🇮🇹 Roma, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy

Hospital Universitario de Gran Canaria Dr Negrin; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Ospedale San Raffaele; 🇮🇹 Segrate, Italy