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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02426307
First received: April 21, 2015
Last updated: October 24, 2016
Last verified: October 2016
  Purpose

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 Intervention
Aortic Valve Stenosis
Procedure: TAVR
Procedure: SAVR

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

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

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

Estimated Enrollment: 75
Study Start Date: April 2015
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
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.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02426307

Locations
Denmark
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
Investigators
Study Director: Lars Søndergaard, MD Department of Cardiology, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark
  More Information

Publications:
Responsible Party: Klaus Fuglsang Kofoed, Associated Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02426307     History of Changes
Other Study ID Numbers: RIGHS.HJE.01
Study First Received: April 21, 2015
Last Updated: October 24, 2016

Keywords provided by Rigshospitalet, Denmark:
Thrombosis
Cardiovascular disease
Oral anticoagulation
bioprosthesis
Multidetector Computed Tomography

Additional relevant MeSH terms:
Thrombosis
Aortic Valve Stenosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on March 24, 2017