Better opening of heart valve implants to reduce leaflet thickening in patients without atrial fibrillation.

Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation: an international, multicentre, randomized controlled trial - OptEx-TAVI

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58047

Enrollment

200

Registered

2025-05-08

Start date

2025-12-08

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve stenosis Calcified aortic valve

Interventions

The systematic use of optimized pre-dilatation of the native aortic valve and optimized postdilatation of the implanted transcatheter aortic valve (TAV) during TAVI.&nbsp

Eligibility

Age

65 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults with severe symptomatic aortic stenosis who are eligible for transcatheter aortic valve implantation (TAVI)Ability to understand and comply with study proceduresProvision of written informed consent

Exclusion criteria

Exclusion criteria: Current indication for oral anticoagulation (e.g., atrial fibrillation, pulmonary embolism)Severe renal impairment (creatinine clearance <15 mL/min calculated with CKD-EPI formula) or receiving dialysisKnown iodine contrast allergy or other contraindications to cardiac CT imaging

Design outcomes

Primary

Measure	Time frame
A least one thickened TAV leaflet involving = 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI	—

Secondary

Measure	Time frame
Cardiac CT (at 3 months) § At least one TAV leaflet with HALT involving = 50% of the leaflet § The rate of TAV leaflets with HALT involving = 25% of the leaflet § The rate of TAV leaflets with HALT involving = 50% of the leaflet Transthoracic echocardiography (TTE) § Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index = 0.25, and less than moderate aortic regurgitation) Composite clinical endpoints § Technical success At discharge § Device success At 3 months § Early safety At 3 months § Clinical efficacy At 1 year Individual clinical components § Individual components of technical success At discharge § Individual components of device success At 3 months § Individual components of early safety At 3 months § Individual components of clinical efficacy At 1 year	—

Measure

Time frame

Cardiac CT (at 3 months) § At least one TAV leaflet with HALT involving = 50% of the leaflet § The rate of TAV leaflets with HALT involving = 25% of the leaflet § The rate of TAV leaflets with HALT involving = 50% of the leaflet Transthoracic echocardiography (TTE) § Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index = 0.25, and less than moderate aortic regurgitation) Composite clinical endpoints § Technical success At discharge § Device success At 3 months § Early safety At 3 months § Clinical efficacy At 1 year Individual clinical components § Individual components of technical success At discharge § Individual components of device success At 3 months § Individual components of early safety At 3 months § Individual components of clinical efficacy At 1 year  

—

Countries

Denmark, Netherlands

Contacts

Public ContactDC Overduin

St. Antonius Ziekenhuis

c.overduin@antoniusziekenhuis.nl0883200931

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)