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

NCT04548726 | Completed

• 1 other identifier: MATCH-BALL
• Study Type: observational
• Target: 416
• Locations: 2 countries
• Sites: 6

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).

Conditions

Aortic Valve Stenosis; Aortic Valve Regurgitation

Keywords

TAVI; TAVR; Balloon-Expandable transcatheter heart valve

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• 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

Study Arms (2)

Sapien 3

Patients with aortic stenosis treated with Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) TAVI

Device: Sapien 3 Transcather Aortic Valve Implant

Myval

Patients with aortic stenosis treated with Myval (Meril Life Sciences Pvt. Ltd., India) TAVI

Device: Myval Transcather Aortic Valve Implant

Interventions

Sapien 3 Transcather Aortic Valve Implant DEVICE

Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.

Sapien 3

Myval Transcather Aortic Valve Implant DEVICE

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

Myval

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Failure to comply with matching criteria.
• Failure to properly analyse images in the echo core-lab.

Sponsors & Collaborators

• Ignacio J. Amat Santos: lead

Study Sites (6)

Policlinico Umberto I

Roma, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Policlinico San Donato

San Donato Milanese, Italy

Location

Ospedale San Raffaele

Segrate, Italy

Location

Hospital Universitario de Gran Canaria Dr Negrin

Las Palmas de Gran Canaria, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinator of Interventional Cardiology Unit

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 14, 2020
• Study Start: June 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); ES (2)