Clinical trial NCT04548726: Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
Official title: Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Aortic Valve Regurgitation
Keywords: TAVI
TAVR
Balloon-Expandable transcatheter heart valve
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).


Eligibility 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.

Primary outcomes:
measure: Mean transvalvular gradients
timeFrame: 30 days
measure: Aortic valve area
timeFrame: 30 days
measure: Aortic valve perivalvular leak
timeFrame: 30 days
measure: Aortic valve central leak
timeFrame: 30 days
measure: Aortic valve global leak
timeFrame: 30 days
Secondary outcomes:
measure: Cardiovascular mortality rate
timeFrame: 30 days
measure: All-cause mortality rate
timeFrame: 30 days
measure: Myocardial infarction rate
timeFrame: 30 days
measure: Bleeding complications rate
timeFrame: 30 days
measure: Acute kidney injury rate
timeFrame: 30 days
measure: Vascular complications rate
timeFrame: 30 days
measure: Conduction disorder rate
timeFrame: 30 days
measure: Re-hospitalization rate
timeFrame: 30 days
measure: Need for permanent pacemaker rate
timeFrame: 30 days
measure: New York Heart Association (NYHA) functional class
timeFrame: 30 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Segrate
country: Italy
facility: Ospedale San Raffaele
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr Negrin
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
References: