Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

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Aortic valve stenosis
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Pilot Study of Cognitive and Functional Outcomes Following TAVI Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement SOURCE XT REGISTRY Imaging Histone Deacetylase in the Heart A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement The PARTNER II Trial: S3iCAP Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development First in Man Study of the JenaValve TAVI Plus System Transfemoral Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR Ascending Aortic Dilation in BiAV After TAVR Safety and Performance Study of the Optimum Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement With Extracorporeal Life System 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Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Brief Title

Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

Official Title

Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial

Brief Summary

      The aim of this study is to evaluate the effect of routine FFR-guided complete
      revascularization with PCI compared to conservative management in patients with concomitant
      coronary artery disease who are undergoing TAVI.

Study Type

Interventional

Primary Outcome

All-cause mortality, myocardial infarction, or urgent revascularization

Secondary Outcome

 All cause mortality

Condition

Coronary Artery Disease

Intervention

PCI

Study Arms / Comparison Groups

 TAVI only
Description:  TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

452

Start Date

September 15, 2017

Completion Date

September 30, 2027

Primary Completion Date

March 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥ 18 years

          2. Severe aortic valve stenosis* and selected for TAVI by a multi-disciplinary Heart Team

          3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery
             ≥ 2.5 mm in diameter

        And one of the following:

          1. Symptomatic (dyspnea corresponding to New York Heart Association (NYHA) class II or
             higher, angina pectoris, or cardiac syncope) or

          2. Asymptomatic but have a decline in left ventricular ejection fraction (LVEF), new
             onset of atrial fibrillation, or LV septal hypertrophy

        Exclusion Criteria:

          1. Life expectancy < 1 year due to other severe non-cardiac disease

          2. Severe renal failure with estimated glomerular filtration rate < 20 ml/min

          3. No PCI-eligible coronary artery stenosis, but rotablation is allowed

          4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction
             (STEMI) or non-STEMI) within 14 days

          5. Significant stenosis in left main stenosis or ostial left anterior descending artery
             (LAD) + ostial left circumflex artery (LCx))

          6. Only stenoses with thrombolysis in myocardial infarction grad < 3

          7. Potential pregnancy

          8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium

          9. More than one chronic total occlusion (CTO)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Engstrøm, MD, PhD, +4535458176, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT03058627

Organization ID

H-16039929

Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark

Collaborators

 Aarhus University Hospital

Study Sponsor

Thomas Engstrøm, MD, PhD, Principal Investigator, Rigshospitalet University Hospital, Denmark

Verification Date

February 2020