Effect of Double-Tap Optimization on Valve Expansion and Hemodynamics in Balloon-expandable Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial (DO-OPT TAVI Trial)
This study will compare two balloon inflation strategies during transcatheter aortic valve implantation (TAVI), a procedure used to replace a severely narrowed aortic valve through a catheter. A balloon-expandable replacement valve may not fully expand during its initial placement. An additional inflation using the same balloon and the same inflation volume, called "Double-Tap," may improve valve expansion and function. Its benefits and risks need to be evaluated in a randomized trial.
This prospective, multicenter study aims to include 250 adults with symptomatic severe aortic stenosis undergoing TAVI with an Edwards SAPIEN-family balloon-expandable valve. After successful valve implantation, participants for whom an additional inflation is considered technically feasible and clinically appropriate will be randomly assigned in equal numbers to Double-Tap or conventional single inflation. Patients requiring therapeutic post-dilatation for moderate or greater leakage around the implanted valve will not undergo randomization.
The main question is whether Double-Tap improves valve expansion immediately after TAVI, as measured using fluoroscopic X-ray images. The study will also compare blood flow through the valve, valve expansion and signs of valve thrombosis on cardiac computed tomography, procedure-related complications, and clinical outcomes. Participants will undergo echocardiography before discharge and at 3-6 and 12 months, and cardiac computed tomography at 3-6 months. Clinical follow-up will continue for at least 12 months, with annual follow-up thereafter until the last enrolled participant completes the 12-month visit.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Young-Guk Ko, Professor
- Telefonnummer: +82-22228-8460
- E-Mail: ygko@yuhs.ac
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients ≥ 19 years old
- Patients undergoing TAVI using a Sapien family valve for severe AS
- Provision of informed consent
Exclusion criteria:
- Subannular calcification
- Bicuspid aortic valve with raphe calcification
- Valve-in-valve TAVI procedure
- Planned major surgery
- Cardiogenic shock or hemodynamic instability
- Chronic kidney disease stage 3b, 4, or 5 (eGFR <45mL/min)
- Thrombocytopenia (platelet count <100,000) or contraindication to antiplatelet therapy or anticoagulation despite clinical indications
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Double-Tap
Participants undergo TAVI with an Edwards SAPIEN-family balloon-expandable valve. After successful initial valve implantation and randomization, one additional balloon inflation is performed using the same delivery balloon and the same inflation volume used for initial deployment. The additional inflation is performed immediately after confirming appropriate valve position and procedural stability. |
Following successful implantation of an Edwards SAPIEN-family balloon-expandable transcatheter heart valve, one additional balloon inflation is performed using the same delivery balloon and the same inflation volume used for initial valve deployment. Balloon inflation volume is not increased for the Double-Tap inflation. The procedure is performed after randomization and confirmation of appropriate valve position and procedural stability. |
|
Aktiver Komparator: No Double-Tap
Participants undergo standard TAVI with an Edwards SAPIEN-family balloon-expandable valve deployed using a single balloon inflation. After successful initial valve implantation and randomization, no planned additional balloon inflation for Double-Tap optimization is performed. |
An Edwards SAPIEN-family balloon-expandable transcatheter heart valve is implanted using a single balloon inflation according to standard practice and the manufacturer's instructions for use. No planned additional balloon inflation for Double-Tap optimization is performed after randomization. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage valve expansion measured by fluoroscopy
Zeitfenster: immediately after TAVI procedure
|
Expansion of the implanted transcatheter heart valve, expressed as a percentage of the manufacturer's nominal cross-sectional area for the implanted valve size. Valve diameters are measured at the inflow, midframe, and outflow levels in three-cusp and cusp-overlap fluoroscopic views. At each level, the diameters from the two views are averaged, and the cross-sectional area is calculated using the circular area formula. Fluoroscopic images are evaluated by independent imaging core laboratory assessors blinded to treatment assignment and clinical outcomes. |
immediately after TAVI procedure
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4-2026-1423
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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