Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

PHASE4CompletedINTERVENTIONAL
Enrollment

858

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

March 21, 2024

Study Completion Date

May 22, 2024

Conditions
Aortic Valve DiseaseAortic Valve StenosisStrokeBleedingVascular ComplicationsMyocardial InfarctionThrombosis Embolism
Interventions
DRUG

Continuation of oral anticoagulants

Oral anticoagulant treatment will not be interrupted before the procedure.

DRUG

Interruption of oral anticoagulants

"Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.~* For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m\^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m\^2 96 hours before procedure.~* For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol.~* After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician."

Trial Locations (22)

8800

AZ Delta, Roeselare

Unknown

A.S.Z. Hospital, Aalst

O.L.V. Hospital, Aalst

ZNA Middelheim, Antwerp

AZ Sint-Jan, Bruges

East Limburg Hospital, Genk

University Hospital Leuven, Leuven

Rigshospitalet Copenhagen, Copenhagen

University Hospital Galway, Galway

Azienda Sanitaria Universitaria Integrata di Trieste, Trieste

National Institute of Cardiac Surgery and Interventional Cardiology, Luxembourg

Amsterdam UMC, Amsterdam

Amphia Hospital, Breda

UMC Groningen, Groningen

Leiden University Medical Center, Leiden

Maastricht UMC+, Maastricht

Radboud UMC, Nijmegen

Erasmus MC, Rotterdam

Haga Hospital, The Hague

UMC Utrecht, Utrecht

Isala, Zwolle

3435CM

St. Antonius Ziekenhuis, Nieuwegein

All Listed Sponsors
lead

St. Antonius Hospital

OTHER

NCT04437303 - Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) | Biotech Hunter | Biotech Hunter