Klinische controle na een klep-sparende hartoperatie|
|- candidate number||19358|
|- NTR Number||NTR4759|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-aug-2014|
|- Secondary IDs||THCHOZ 2014-08 |
|- Public Title||Klinische controle na een klep-sparende hartoperatie|
|- Scientific Title||Clinical outpatient control after valve-sparing hartoperation|
|- ACRONYM||Tiron David|
|- hypothesis||The main objective is to determine the early and late survival and reoperation outcome of VSARR in patients suffering from aortic root aneurysm with or without aortic regurgitation. Furthermore, we will evaluate the quality of using a SF-36 form. The second objective is evaluate the valve related complications after VSARR. |
|- Healt Condition(s) or Problem(s) studied||Heart surgery, Valve disease|
|- Inclusion criteria||• All patients aged 18 years or older who received a valve sparing root reimplantation (Tirone David) at the Erasmus MC since 2000, not reoperated on the aortic valve
Signed informed consent by the patient and the investigator.
|- Exclusion criteria||Patients who are unable to give informed consent.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-nov-2014|
|- planned closingdate||1-jul-2015|
|- Target number of participants||40|
|- Interventions||- TTE: transthoracic echocardiogram |
- SF36: standardized "quality of life" form
|- Primary outcome||Freedom of reoperation, survival and quality of life.|
|- Secondary outcome||Valve related complications.|
|- Timepoints||Planned start 01-11-2014 |
Outpatient visits from 01-11-2014 until 01-06-2015.
Data collection from 01-11-2014 until 01-06-2015.
Writing manuscript and submission: 01-07-2015
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MD B. Arabkhani|
|- CONTACT for SCIENTIFIC QUERIES||MD B. Arabkhani|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|- Publications||• Does pregnancy influence the durability of human aortic valve substitutes?
Bardia Arabkhani, MSc, Helena J. Heuvelman, MD, MSc, Ad J.J.C. Bogers, MD, PhD, M. Mostafa Mokhles, MSc, Jolien W. Roos-Hesselink, MD, PhD, Johanna J.M. Takkenberg, MD, PhD. J Am Coll Cardiol. 2012;60(19):1991-1992. doi:10.1016/j.jacc.2012.06.055
• Outcome of Pregnancy in Women who received a Human or Mechanical Aortic Valve Substitute.
H.J. Heuvelman, MD, B. Arabkhani, P.G. Pieper, MD, PhD, J.J.M. Takkenberg, MD, PhD, J.M.J. Cornette, A.J.J.C. Bogers , MD, PhD, J.W Roos-Hesselink, MD, PhD. Am J Cardiol. 2012 Nov 20. doi:pii: S0002-9149(12)02293-X. 10.1016/j.amjcard.2012.09.035.
• Therapeutic decisions for patients with symptomatic severe aortic stenosis: room for improvement?
van Geldorp MW, van Gameren M, Kappetein AP, Arabkhani B, de Groot-de Laat LE, Takkenberg JJ, Bogers AJ. Eur J Cardiothorac Surg. 2009 Jun;35(6):953-7; discussion 957. Epub 2009 Mar 20.
|- Brief summary||Rationale: Provide insight in VSARR performed in Erasmus MC|
Objective: The main objective is to determine the early and late survival and reoperation outcome of VSARR in patients suffering from aortic root aneurysm with or without aortic regurgitation. Furthermore, we will evaluate the quality of using a SF-36 form. The second objective is evaluate the valve related complications after VSARR.
Study design: Single-centre hospital-based retrospective/prospective cohort study.
All patients who underwent an VSARR at an age above 18 years in the Erasmus MC since 2000 until now.
Intervention (if applicable): All patients will be asked to visit our outpatient clinic for an echocardiogram and to fill in a quality of life (SF-36) form.
Main study parameters/endpoints:
Reoperation and survival outcome. Secondary, valve related complications.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: We expect that the burden associated with participation will be mainly emotional due to the SF-36 questionnaire. Patients have to visit our outpatient clinic which may have organizational burdens (taking a few ours off from work etc.) and to travel to the Erasmus MC.There is no further risk associated with participation because our study population consist of patients who are compos mentis and to collect our data, we use the hospital information systems. Patients may benefit from the knowledge of a potential change in the hemodynamics or change in valve function seen on the echocardiogram, which may lead to an altered, improved treatment.
|- Main changes (audit trail)|
|- RECORD||27-aug-2014 - 22-sep-2014|
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