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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis, Severe
• Intervention / Treatment: Device: Transcatheter Heart Valve

• Study Type: Interventional
• Enrollment (Estimated): 604
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elsbeth C. Noppers, MD; Phone Number: +31 (0) 20 566 2893; Email: e.c.noppers@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

1. TAVI as decided by local multidisciplinary heart team

2. 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
3. Written informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-expanding Evolut transcatheter heart valve series	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.; Other Names: TAVI; TAVR; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement
Experimental: Balloon-expandable Myval transcatheter heart valve series	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.; Other Names: TAVI; TAVR; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite safety end point as per VARC-3 guidelines	A composite safety end point as per VARC-3 guidelines that consists of all-cause mortality, all stroke, type 2 to 4 bleeding, major vascular access-related or cardiac structural complications, acute kidney injury stage 3 to 4, moderate or severe aortic regurgitation, new permanent pacemaker implantation due to conduction abnormalities, surgery or intervention related to the device at 30 days after TAVI as defined in accordance with criteria stated by the third Valve Academic Research Consortium (VARC-3).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite safety endpoint as per VARC-3 guidelines	All clinical end points will be assessed after TAVI	Annually, up to 5 years
Hemodynamic performance	Hemodynamic performance will be assessed by transthoracic echocardiography	At 30 days (+2 months) and at 1, 3 and 5 years
Patient-reported outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12		Yearly, up to 5 years

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Ronak Delewi, Prof. Dr., Amsterdam University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): August 1, 2033

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: TAVI; TAVR; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement; THV; Transcatheter heart valve; Balloon-expandable transcatheter heart valve; Balloon-expandable THV; Self-expanding THV; Self-expanding transcatheter heart valve
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: NL-011489

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No