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

NCT07689279 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: NL-011489
• Study Type: interventional
• Target: 604
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Aortic Stenosis, Severe

Keywords

TAVI; TAVR; Balloon-expandable THV; Transcatheter heart valve; THV; Self-expanding THV; Self-expanding transcatheter heart valve; Balloon-expandable transcatheter heart valve; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• A composite safety endpoint as per VARC-3 guidelines

  Annually, up to 5 years

• Hemodynamic performance

  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

Study Arms (2)

Self-expanding Evolut transcatheter heart valve series

ACTIVE COMPARATOR

Device: Transcatheter Heart Valve

Balloon-expandable Myval transcatheter heart valve series

EXPERIMENTAL

Device: Transcatheter Heart Valve

Interventions

Transcatheter Heart Valve DEVICE

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

Also known as: TAVI, TAVR, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement

Balloon-expandable Myval transcatheter heart valve series; Self-expanding Evolut transcatheter heart valve series

Eligibility Criteria

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

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Ronak Delewi, Prof. Dr.

  Amsterdam University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsbeth C. Noppers, MD

CONTACT

+31 (0) 20 566 2893; e.c.noppers@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): August 1, 2033
• Last Updated: July 8, 2026

Record last verified: 2026-07