Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT

NCT02426307 | Active Not Recruiting

• 1 other identifier: RIGHS.HJE.01
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Thrombosis; Cardiovascular disease; Oral anticoagulation; bioprosthesis; Multidetector Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology

  At least 21 days post-procedure

Secondary Outcomes (1)

• Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology

  At least 21 days post-procedure

Study Arms (2)

Transcatheter Aortic Valve Replacement

TAVR: Portico (St Jude Medical), CoreValve (Medtronic), Lotus (Boston Scientific), Edwards Sapien 3 (Edwards LifeSciences),

Procedure: TAVR

Surgical aortic valve replacement

SAVR: Perimount (Edwards), Epic (St Jude Medical), Trifecta (St Jude Medical)

Procedure: SAVR

Interventions

TAVR PROCEDURE

TAVR: Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement

SAVR PROCEDURE

SAVR: surgical Aortic Valve Replacement

Surgical aortic valve replacement

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Successful TAVR or SAVR performed at Rigshospitalet, Copenhagen, Denmark

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Cedars-Sinai Medical Center: collaborator

Study Sites (1)

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (3)

• Thyregod HG, Steinbruchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrom T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Sondergaard L. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015 May 26;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014. Epub 2015 Mar 15.

  PMID: 25787196 BACKGROUND

• Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

  PMID: 26436963 RESULT

• Sondergaard L, De Backer O, Kofoed KF, Jilaihawi H, Fuchs A, Chakravarty T, Kashif M, Kazuno Y, Kawamori H, Maeno Y, Bieliauskas G, Guo H, Stone GW, Makkar R. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J. 2017 Jul 21;38(28):2201-2207. doi: 10.1093/eurheartj/ehx369.

  PMID: 28838044 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Thrombosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Lars Søndergaard, MD

  Department of Cardiology, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2018
• Study Completion (Estimated): April 1, 2030
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

DK (1)