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ACTIVE NOT RECRUITING

NCT04310046

Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

Sponsor: University of Zurich

View on ClinicalTrials.gov

Summary

The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

986

Start Date

2020-09-30

Completion Date

2031-07

Last Updated

2026-06-16

Healthy Volunteers

Conditions

Aortic Stenosis Coronary Artery Disease TAVI PCI

Interventions

PROCEDURE

PCI before TAVI

TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.

PROCEDURE

PCI after TAVI

Inclusion Criteria: 1. Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a multidisciplinary Heart Team. 2. Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria: 1. Dyspnea 2. Angina symptoms 3. Syncope 4. Decline in left ventricular ejection fraction \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity \>5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, or severe pulmonary hypertension with systolic pulmonary artery pressure \>60 mmHg) according to current guidelines. 3. At least one coronary artery lesion with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter and Thrombolysis in Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 days before or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator. 4. Written informed consent. Exclusion Criteria: 1. TAVI by transapical, subclavian, or transaortic access 2. Admission with acute myocardial infarction within 30 days before randomization 3. Elective coronary revascularization within 3 months before randomization 4. Previous coronary artery bypass grafting (CABG) 5. Syntax Score I ≥33 6. Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation 7. Planned open heart surgery 8. Known pregnancy at the time of inclusion 9. Life expectancy \<1 year due to other severe non-cardiac disease 10. Participation in another clinical study with an investigational product 11. Acute COVID-19 infection 12. Patient with previously treated aortic stenosis

Locations (48)

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

University Hospital Dijon

Dijon, France

The Clinique de l'Infirmerie Protestante

Lyon, France

Cardiology Department, CHU Timone Marseille

Marseille, France

Arnault Tzanck Institute Saint Laurent du Var

Nice, France

Toulouse University Hospital

Toulouse, France

Zentralklinik Bad Berka

Bad Berka, Germany

Heart and Vascular Centre Bad Bevensen

Bad Bevensen, Germany

Universitäts-Herzzentrum Freiburg Bad Krozingen, Freiburg & Bad Krozingen

Bad Krozingen, Germany

Campus Kerckhoff of the Justus Liebig University Giessen

Bad Nauheim, Germany

Cardiovascular Center Bad Neustadt/Saale

Bad Neustadt an der Saale, Germany

Schüchtermann-Clinic Bad Rothenfelde

Bad Rothenfelde, Germany

Segeberger Kliniken GmbH

Bad Segeberg, Germany

German Heart Center of Charité

Berlin, Germany

University Hospital Bergmannsheil

Bochum, Germany

Herzzentrum Dresden

Dresden, Germany

Heinrich-Heine University

Düsseldorf, Germany

Helios Hospital Erfurt

Erfurt, Germany

University Hospital Erlangen

Erlangen, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Klinikum Fulda

Fulda, Germany

Academic Teaching Hospital of the Friedrich-Alexander-University Erlangen-Nuremberg

Fürth, Germany

Justus-Liebig University of Giessen

Giessen, Germany

University Heart and Vascular Centre Hamburg

Hamburg, Germany

Klinikum Ingolstadt

Ingolstadt, Germany

University Hospital Jena

Jena, Germany

Municipial Hospital Karlsruhe

Karlsruhe, Germany

University Hospital Schleswig-Holstein

Kiel, Germany

Heart Center Leipzig at University of Leipzig

Leipzig, Germany

Otto-von-Guericke University Magdeburg

Magdeburg, Germany

LMU Munich

Munich, Germany

TUM University Hospital

Munich, Germany

University of Oldenburg

Oldenburg, Germany

Helios Hospital Pforzheim

Pforzheim, Germany

Prosper Hospital

Recklinghausen, Germany

University Hospital Regensburg

Regensburg, Germany

Krankenhaus der Barmherzigen Brüder

Trier, Germany

Ulm University Heart Center

Ulm, Germany

Azienda Santa Croce e Carle

Cuneo, Italy

IRCCS Azienda Ospedaliera Metropolitana

Genova, Italy

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, Italy

Cardiology Department Azienda Ospedaliera Ordine Mauriziano di Torino

Turin, Italy

Leiden University Medical Center

Leiden, Netherlands

Thoraxcenter, Erasmus MC

Rotterdam, Netherlands

University Hospital Basel

Basel, Switzerland

Geneva University Hospitals

Geneva, Switzerland

Lausanne University Hospital

Lausanne, Switzerland

University Hospital Zürich, Cardiology Department

Zurich, Switzerland