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

• ClinicalTrials.gov Identifier: NCT04548726
• Recruitment Status: Completed
• First Posted: September 14, 2020
• Last Update Posted: January 28, 2021
• Sponsor: Ignacio J. Amat Santos
• Information provided by (Responsible Party): Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid

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
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: June 1, 2018
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: September 30, 2020

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Mean transvalvular gradients [ Time Frame: 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.
2. Aortic valve area [ Time Frame: 30 days ]
   Echography measured Aortic valve area
3. Aortic valve perivalvular leak [ Time Frame: 30 days ]
   Echography measured perivalvular leak
4. Aortic valve central leak [ Time Frame: 30 days ]
   Echography measured central leak
5. Aortic valve global leak [ Time Frame: 30 days ]
   Echography measured global leak

Secondary Outcome Measures :

1. Cardiovascular mortality rate [ Time Frame: 30 days ]
2. All-cause mortality rate [ Time Frame: 30 days ]
3. Myocardial infarction rate [ Time Frame: 30 days ]
4. Bleeding complications rate [ Time Frame: 30 days ]
5. Acute kidney injury rate [ Time Frame: 30 days ]
6. Vascular complications rate [ Time Frame: 30 days ]
7. Conduction disorder rate [ Time Frame: 30 days ]
8. Re-hospitalization rate [ Time Frame: 30 days ]
9. Need for permanent pacemaker rate [ Time Frame: 30 days ]
10. New York Heart Association (NYHA) functional class [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Italy

Policlinico Umberto I

Roma, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Policlinico San Donato

San Donato Milanese, Italy

Ospedale San Raffaele

Segrate, Italy

Spain

Hospital Universitario de Gran Canaria Dr Negrin

Las Palmas De Gran Canaria, Spain

Hospital Clínico San Carlos

Madrid, Spain

Sponsors and Collaborators

Ignacio J. Amat Santos

More Information

• Responsible Party: Ignacio J. Amat Santos, Coordinator of Interventional Cardiology Unit, Hospital Clínico Universitario de Valladolid
• ClinicalTrials.gov Identifier: NCT04548726
• Other Study ID Numbers: MATCH-BALL
• First Posted: September 14, 2020
• Last Update Posted: January 28, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid:

TAVI; TAVR; Balloon-Expandable transcatheter heart valve

Additional relevant MeSH terms:

Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction