Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT

Aortic Valve Stenosis Clinical Trial

— SAVORY  

Official title:

Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02426307
• Other study ID #: RIGHS.HJE.01
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: April 2030

Study information

• Verified date: December 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

METHODS:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: April 2030
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Thrombosis

Intervention

Procedure:
• TAVR
TAVR: Transcatheter Aortic Valve Replacement
• SAVR
SAVR: surgical Aortic Valve Replacement

Locations

Country	Name	City	State
Denmark	Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Cedars-Sinai Medical Center

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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, Sonderga — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology		At least 21 days post-procedure
Secondary	Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology		At least 21 days post-procedure