Selection of Transcatheter Heart vaLve With Intermediate Sizing in Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Replacement

Official title

Selection of transcathEter Heart vaLve With intermEdiate Sizing in Patients With Severe aortiC Stenosis Treated With Transcatheter Aortic Valve Replacement

Overview

Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations. Two types of transcatheter heart valves, balloon-expandable and self-expanding, exhibit distinct hemodynamic and structural characteristics that influence procedural strategy and long-term durability. Accurate valve sizing is crucial for procedural success, as both undersizing and oversizing are associated with procedural complications, including aortic regurgitation, conduction disorders, valve embolization, annular rupture, and increased leaflet stress which may impair long-term durability. However, optimal annular sizing remains challenging due to the complex three-dimensional anatomy of the aortic annulus, which is oval, crown-shaped, dynamically deforming, and variably oriented. These anatomical features often lead to "grey zones" in clinical sizing charts, resulting in so-called borderline annuli in which the measured annular dimensions may indicate two suitable valve sizes. Borderline annuli are frequently encountered in patients undergoing TAVI with self-expanding valves (i.e., Evolut transcatheter heart valve series) due to a limited number of sizes (23, 26, 29 and 34 mm). Consequently, under- or oversizing of self-expanding valves is often required. However, sizing of transcatheter heart valves in borderline annuli is associated with a greater likelihood of procedural complications, higher rates of aortic regurgitation, and higher transvalvular gradients.9,11 New generation balloon-expandable valves (i.e., Myval transcatheter heart valve series) are introduced with intermediate (21.5, 24.5, 27.5 mm) and extra-large (30.5, 32 mm) valve sizes that are not available for the Evolut platform. These additional size ranges potentially offer more precise annular sizing, reducing the need for under- or oversizing and improving short- and long-term hemodynamic performance. The SELECT TAVR trial will evaluate whether the expanded size range of the balloon-expandable Myval transcatheter heart valves is noninferior compared to the self-expanding Evolut transcatheter heart valve series in patients with borderline annular dimensions undergoing TAVI with respect to the composite safety end point of the third Valve Academic Research Consortium (VARC-3) at 30 days. Objectives: The primary objective of the current trial is to determine whether the Myval transcatheter heart valve series is noninferior to the Evolut transcatheter heart valve series in patients with borderline annular dimensions undergoing TAVI with respect to the composite safety end point of the third Valve Academic Research Consortium (VARC-3) at 30 days Secondary objectives: The secondary objectives of the current trial include: 1) Hemodynamic performance as assessed by invasive hemodynamic parameters as well as by transthoracic echocardiography at 30 days (+2 months), and longer-term follow-up; and 2) Long-term clinical outcomes with follow-up up to 5 years. Study design: The proposed SELECT TAVR trial is an investigator-initiated, open-label, multicenter, randomized controlled, noninferiority trial with blind end point adjudication. Study population: The SELECT TAVR trial will focus on patients referred for TAVI in whom CT-derived annular dimensions fall within borderline annulus ranges

Interventions

• Device Transcatheter Heart Valve
  All subjects undergo transcatheter aortic valve implantation because of symptomatic severe aortic valve stenosis. This is a routine medical procedure, not a study intervention.

Primary outcome measures

• A composite safety end point as per VARC-3 guidelines [Time frame: 30 days]

Secondary outcome measures (3)

• A composite safety endpoint as per VARC-3 guidelines [Time frame: Annually, up to 5 years]
• Hemodynamic performance [Time frame: At 30 days (+2 months) and at 1, 3 and 5 years]
• Patient-reported outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 [Time frame: Yearly, up to 5 years]

Eligibility criteria

A potential participant is deemed eligible for trial participation if the following criteria are met:

• TAVI as decided by local multidisciplinary heart team
• CT-derived annular perimeters fall within the following ranges:

• 55.5 - 57.5 mm
• 61.0 - 64.5 mm
• 70.5 - 74.0 mm
• 79.5 - 84.0 mm
• 92.0 - 96.0 mm
• Written informed consent

Exclusion criteria

A potential participant will be excluded from trial participation in case of inability to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07689279 · NL-011489

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗