SAVORY: Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02426307

Collaborator

Cedars-Sinai Medical Center (Other)

274

Enrollment

Location

180

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

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.

Study Design

Study Type:

Observational

Anticipated 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 :

Apr 1, 2015

Actual Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Apr 1, 2030

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology [At least 21 days post-procedure]

Secondary Outcome Measures

Frequency of abnormal aortic valve bioprosthesis leaflet mobility and morphology [At least 21 days post-procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen	Copenhagen		Denmark	2100