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

Sponsor

Ignacio J. Amat Santos (Other)

Overall Status

Completed

CT.gov ID

NCT04548726

Collaborator

(none)

416

Enrollment

Locations

Actual Duration (Months)

69.3

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Valve Regurgitation	Device: Sapien 3 Transcather Aortic Valve Implant Device: Myval Transcather Aortic Valve Implant

Study Design

Study Type:

Observational

Actual Enrollment :

416 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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 central leak [30 days]
Echography measured central leak
Aortic valve global leak [30 days]
Echography measured global leak

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Policlinico Umberto I	Roma	Italy
2	Policlinico Universitario Agostino Gemelli	Roma	Italy
3	Policlinico San Donato	San Donato Milanese	Italy
4	Ospedale San Raffaele	Segrate	Italy
5	Hospital Universitario de Gran Canaria Dr Negrin	Las Palmas De Gran Canaria	Spain
6	Hospital Clínico San Carlos	Madrid	Spain