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van CCT (UK)


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van CCT (UK)


Prediction of clinical improvement following biventricular pacing in patients with end-stage heart failure using tissue Doppler echocardiography.


- candidate number1691
- NTR NumberNTR482
- ISRCTNISRCTN09353557
- Date ISRCTN created26-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitlePrediction of clinical improvement following biventricular pacing in patients with end-stage heart failure using tissue Doppler echocardiography.
- Scientific TitlePrediction of clinical improvement following biventricular pacing in patients with end-stage heart failure using tissue Doppler echocardiography.
- ACRONYMN/A
- hypothesisIn patients with end-stage heart failure (NYHA class III or IV, LVEF <35%, QRS duration >120 ms, LBBB), the dyssynchrony of the left ventricle is the most important predictor of clinical benefit.
The dyssynchrony of the left ventricle can be assessed (at any time before implantation) non-invasively by Tissue Doppler Imaging(TDI).
Thus, information on dyssynchrony derived from TDI may predict clinical benefit from biventricular pacing (BVP).
- Healt Condition(s) or Problem(s) studiedHeart diseases, Heart failure
- Inclusion criteria1. Severe heart failure (NYHA class III or IV);
2. Severely depressed left ventricular ejection fraction (LVEF <35%);
3. QRS exhibiting left bundle branch block configuration with a duration >120 ms.
- Exclusion criteriaN/A
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-mei-2003
- planned closingdate1-mei-2007
- Target number of participants60
- InterventionsPatients will undergo BVP implantation based on traditional selection criteria. VO2 max and TDI will be performed before and 3 months after BVP implantation. From these patients the TDI criteria which optimally predict clinical improvement (in VO2 max) will be derived.
- Primary outcomeTo develop non-invasive selection criteria (using echocardiography) to identify patients with end-stage heart failure who are likely to benefit from biventricular pacing.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. J.J. Bax
- CONTACT for SCIENTIFIC QUERIESDr. J.J. Bax
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-sep-2005 - 27-nov-2009


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