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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation
• Intervention / Treatment: Device: Sapien 3 Transcather Aortic Valve Implant; Device: Myval Transcather Aortic Valve Implant

• Study Type: Observational
• Enrollment (Actual): 416

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Policlinico Umberto I
  • Roma, Italy
    • Policlinico Universitario Agostino Gemelli
  • San Donato Milanese, Italy
    • Policlinico San Donato
  • Segrate, Italy
    • Ospedale San Raffaele
• Spain
  • Las Palmas De Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Dr Negrin
  • Madrid, Spain
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who underwent TAVI with any of the previously explained self-expandable devices in the participating institutions and have at least one transthoracic echocardiography after TAVI procedure will be included. Main baseline and procedural characteristics as well as in-hospital outcomes will be drawn from the prospective database available at each institution.

Echocardiographic exams will be centrally analysed by two independent operators blinded to the TAVI device and the clinical outcomes as well as to any clinical information of the patients.

Subjects treated with each device will be matched with patients who had undergone transcatheter aortic valve implantation with the alternative devices and clinical and echocardiographic variables will be compared. The final matching will be performed by random sampling without replacement.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sapien 3; Patients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI	Device: 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.
Myval; Patients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI	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.

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	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

Collaborators and Investigators

• Sponsor: Ignacio J. Amat Santos

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Balloon-Expandable transcatheter heart valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic
• Other Study ID Numbers: MATCH-BALL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No