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Evaluation of the clinical impact of ventricular dyssynchrony in patients with corrected tetralogy of fallot


- candidate number3683
- NTR NumberNTR1388
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2008
- Secondary IDsp08.023 METC LUMC
- Public TitleEvaluation of the clinical impact of ventricular dyssynchrony in patients with corrected tetralogy of fallot
- Scientific TitleEvaluation of the effect of pulmonary valve replacement on ventricular dyssynchrony in young patients with corrected tetralogy of fallot
- ACRONYMN/A
- hypothesisImprovement of the RV function by pulmonary valve replacement will result in improvement of RV dyssynchrony in corrected tetralogy of Fallot patients
- Healt Condition(s) or Problem(s) studiedVentricular dyssynchrony, Pulmonary valve replacement, Tetralogy of Fallot
- Inclusion criteria1. Corrected tetralogy of fallot
2. >8 year
3. Scheduled for pulmonary valve replacement
- Exclusion criteria1. Claustrophobia
2. Renal disease
3. Cardiac arrythmia
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 23-jul-2008
- planned closingdate1-mrt-2011
- Target number of participants20
- InterventionsGroup: patients with corrected Tetralogy of Fallot who undergo pulmonary valve replacement.

Intervention: pulmonary valve replacement (PVR), surgical or percutaneous
- Primary outcomePrimary outcome: Differences in time to peak systolic velocity between different segments of the right ventricle:
- Right ventricular outflow tract
- Right ventricular free wall
- Right ventricular septum.

The greatest difference in time to peak systolic velocity of the segments (latest peak systolic velocity minus earliest peak systolic velocity) will be used as a measure of dyssynchrony, and this value will be compared before and after PVR
- Secondary outcomeEffect of PVR on ventricular function (eg. volume, diastolic function, E/A ratio, pulmonary regurgitation, Vo2 max, clinical condition)
- Timepoints- approximately 3-6 months before PVR
- approximately 3-6 months after PVR
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD A.E. Hulst, van der
- CONTACT for SCIENTIFIC QUERIESMD A.E. Hulst, van der
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Willem-Alexander. Kinder- en Jeugd Centrum
- PublicationsN/A
- Brief summaryProspective study to evaluate the effect of pulmonary valve replacement on mechanical ventricular dyssynchrony in young corrected tetralogy of Fallot patients
- Main changes (audit trail)
- RECORD23-jul-2008 - 5-aug-2008


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