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CArdiac CT for theraPeutic sTratification in low gradient presUmed seveRE Aortic Stenosis with preserved left ventricular ejection fraction.
Synopsis
Inclusion criteria
Exclusion criteria
Study flowchart
Study schedule
Contact
Study design: The CAPTURE AS trial is a single centre, non-randomized, intervention trial designed to evaluate the efficacy of TAVR in improving exercise capacity in patients with LG severe AS with preserved LVEF reclassified based on hybrid CT/TTE-derived parameters from severe to moderate AS with fusion AVA 1.0 - 1.2 cm2. Patients with LG severe AS reclassified to moderate AS with fusion AVA >1.2 cm2 and with low aortic valve calcium score (men <1600; women <800) will be managed conservatively and will be included into a registry for further follow up. Patients with LG severe AS in whom fusion AVA remains <1.0 cm2 will be referred for TAVR and will be included into the registry for further follow up.
Study patients: The CAPTURE-AS trial will include patients with low mean transvalvular aortic pressure gradient (<40 mmHg), severe AS (defined by echocardiographic aortic valve area <1.0 cm2 or <0.6 cm2/m2) and preserved LVEF (LVEF ≥50%), who have been reclassified based on hybrid CT-/TTE-derived parameters from severe to moderate AS with fusion AVA of 1.0 - 1.2 cm2.
The CAPTURE-AS registry will include the following patients: patients with LG severe AS reclassified to moderate AS with fusion AVA >1.2 cm2 and with low aortic valve calcium score (men <1600; women <800).
Patients with LG severe AS in whom fusion AVA remains <1.0 cm2 will be entered into a registry for further follow up.
Primary endpoint: The primary endpoint of the CAPTURE AS trial is change in exercise capacity assessed by 6 MWT from baseline to 6 months in patients with LG severe AS with preserved LVEF reclassified from severe to moderate AS with fusion AVA 1.0 - 1.2 cm2.
Secondary endpoint: The secondary endpoints of the CAPTURE AS trial in patients with LG severe AS with preserved LVEF reclassified from severe to moderate AS with fusion AVA 1.0 - 1.2 cm2 are:
Sample size: The CAPTURE AS trial is powered on a sample size based on the primary endpoint and will include 60 patients with LG severe AS with preserved LVEF reclassified from severe to moderate AS with fusion AVA 1.0 - 1.2 cm2 and referred for TAVR.
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Principal investigator (PI): dr. L. van Heerebeek; tel. 020-599 4846; email: l.vanheerebeek@olvg.nl
Study coordinator: drs. T. Oomens; tel. 020-599 4698; e-mail: t.oomens@olvg.nl
Study nurse: F.R. Bosman; tel. 020-599 3440; e-mail: f.r.bosman@olvg.nl