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Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT (SAVORY)

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ClinicalTrials.gov Identifier: NCT02426307
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : December 12, 2022
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark

Brief Summary:

TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. The frequency of this potentially ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this condition is difficult to detect.

The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise for the evaluation of valve leaflet mobility and morphology.

The purpose of this study is in an observational design to assess the frequency of subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon as well as its relation to medical treatment and MACCE will be assessed.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: TAVR Procedure: SAVR

Detailed Description:

MATERIAL In the period from May 2014 to November 2015, a random subset of patients who underwent transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) were offered intensified post-procedural clinical and imaging follow-up. It is intended to examine a variety of implanted transcatheter heart valves (THV) as well as surgical aortic valve bioprosthesis.


Post-procedural clinical and imaging follow-up encompasses the following:

  • Thoracic 4DCT scanning - with evaluation of leaflet morphology and leaflet motion
  • Transthoracic echocardiography - with evaluation of peak aortic valve gradient, mean aortic valve gradient, aortic valve area/effective orifice area (cm2), paravalvular leakage, central aortic valve regurgitation, and left ventricular ejection fraction
  • Clinical follow-up: improvement in New York Heart Association (NYHA) class dyspnea, and major adverse cardiac and cerebro-vascular events (MACCE)
  • Registration of anti-coagulation/anti-thrombotic therapy following aortic valve replacement

All patients will receive the above-described post-procedural follow-up at two different time-points:

  • The first follow-up contact will be planned 30 to 180 days after the TAVR or SAVR procedure. The medical treatment will not be changed based on the generated data.
  • The second follow-up contact will be planned 120 to 180 days after the first follow-up contact (see above). This second follow-up offers the possibility to study the 'natural evolution' of this process. In those patients with an abnormal leaflet morphology and/or motion, a treatment with rivaroxaban 20mg daily will be initiated.
  • Those patients initiated on rivaroxaban after the second follow-up will be called in for a third clinical and imaging follow-up, with focus on leaflet morphology and/or motion after rivaroxaban therapy. In case of persistent abnormal leaflet morphology and/or motion despite NOAC, a treatment with Marevan (INR 2-3) will be initiated.
  • Those patients initiated on Marevan after the third follow-up will be called in for a fourth clinical and imaging follow-up contact.

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Study Type : Observational
Estimated Enrollment : 274 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging
Study Start Date : April 2015
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort Intervention/treatment
Transcatheter Aortic Valve Replacement
TAVR: Portico (St Jude Medical), CoreValve (Medtronic), Lotus (Boston Scientific), Edwards Sapien 3 (Edwards LifeSciences),
Procedure: TAVR
TAVR: Transcatheter Aortic Valve Replacement

Surgical aortic valve replacement
SAVR: Perimount (Edwards), Epic (St Jude Medical), Trifecta (St Jude Medical)
Procedure: SAVR
SAVR: surgical Aortic Valve Replacement

Primary Outcome Measures :
  1. Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology [ Time Frame: At least 21 days post-procedure ]

Secondary Outcome Measures :
  1. Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology [ Time Frame: At least 21 days post-procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A random subset of patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) because of aortic valve stenosis.

Inclusion Criteria:

Successful TAVR or SAVR performed at Rigshospitalet, Copenhagen, Denmark

Exclusion Criteria:

  • renal dysfunction (eGFR <25 ml/min)
  • TAVR-in-TAVR
  • Patients living in Greenland or the Faroe Islands

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426307

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Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Cedars-Sinai Medical Center
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Study Director: Lars Søndergaard, MD Department of Cardiology, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Klaus Fuglsang Kofoed, Associated Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02426307    
Other Study ID Numbers: RIGHS.HJE.01
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Keywords provided by Klaus Fuglsang Kofoed, Rigshospitalet, Denmark:
Cardiovascular disease
Oral anticoagulation
Multidetector Computed Tomography
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction