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

Aortic Valve Stenosis Clinical Trial

— MATCH-BALL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548726
• Other study ID #: MATCH-BALL
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: Hospital Clínico Universitario de Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Roma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Policlinico San Donato	San Donato Milanese
Italy	Ospedale San Raffaele	Segrate
Spain	Hospital Universitario de Gran Canaria Dr Negrin	Las Palmas De Gran Canaria
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ignacio J. Amat Santos

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Aortic valve area	Echography measured Aortic valve area	30 days
Primary	Aortic valve perivalvular leak	Echography measured perivalvular leak	30 days
Primary	Aortic valve central leak	Echography measured central leak	30 days
Primary	Aortic valve global leak	Echography measured global leak	30 days
Secondary	Cardiovascular mortality rate		30 days
Secondary	All-cause mortality rate		30 days
Secondary	Myocardial infarction rate		30 days
Secondary	Bleeding complications rate		30 days
Secondary	Acute kidney injury rate		30 days
Secondary	Vascular complications rate		30 days
Secondary	Conduction disorder rate		30 days
Secondary	Re-hospitalization rate		30 days
Secondary	Need for permanent pacemaker rate		30 days
Secondary	New York Heart Association (NYHA) functional class		30 days