CArdiac CT for theraPeutic sTratification in low gradient presUmed seveRE Aortic Stenosis with preserved left ventricular ejection fraction.
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:
- Exercise tolerance assessed by cardiopulmonary exercise testing (CPET) at 6 months
- Change in exercise capacity assessed by 6MWT from baseline to 12, 24 and 36 months
- Change in NYHA class and quality of life from baseline to 6, 12, 24 and 36 months
- Change in plasma levels of NT-proBNP from baseline to 6, 12, 24 and 36 months
- Change in echocardiographic structural and functional characteristics from baseline to 6, 12, 24 and 36 months, including:
- LV dimensions, volumes (2D and 3D if possible) and wall thickness
- LV systolic and diastolic function parameters
- Left atrial (LA) dimensions and function
- RV dimensions, volumes (2D and 3D if possible) and wall thickness
- RV systolic and diastolic function
- Pulmonary artery systolic pressure
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.
- Written informed consent must be obtained prior to inclusion
- Heart Team consisting of at least one interventional cardiologist, imaging cardiologist and thoracic surgeon agree on indication, treatment proposal and eligibility for inclusion based on their clinical judgment (including anatomy assessment, risk factors, etc.)
- Echocardiographic severe AS (≤1 cm2; or <0.6 cm2/m2) according to continuity equation
- Preserved LVEF ≥50%
- Low mean transvalvular aortic pressure gradient (<40 mmHg)
- Age ≥60 years
- Cardiac CT performed with assessment of LVOT area and AV calcium score (Agatston AV score)
- Patient has suitable anatomy to allow TAVR
- Patient demonstrates symptoms suspicious of heart failure or severe AS
- Hypersensitivity or contraindication to aspirin, heparin, clopidogrel or sensitivity for contrast media which cannot be adequately pre-medicated
- Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy
- Concomitant valvular disease, defined as more than moderate aortic valve regurgitation, and/or more than moderate mitral valve regurgitation and/or stenosis
- Ongoing sepsis, including active endocarditis
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 6 weeks of inclusion
- Active gastrointestinal (GI) bleeding within the past 3 months
- Subject refuses blood transfusion
- Severe dementia
- Estimated life expectancy of less than 24 months due to associated non-cardiac comorbidities
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject form appropriate consent or adherence to the protocol required follow-up exams
- Reduced LV function (LVEF <50%)
- Native aortic annulus size <18 mm or >30 mm per baseline diagnostic imaging
- Sinus of valsalva diameter <25 mm or sinus of valsalva height <15 mm
- Concomitant planned coronary artery bypass graft or additional valve intervention
- Hypertrophic obstructive cardiomyopathy
- Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation
- Transarterial access not able to accommodate an 18Fr sheath
- Patient not being able to exercise or perform 6 MWT
Principal investigator (PI): dr. L. van Heerebeek; tel. 020-599 4846; email: email@example.com
Study coordinator: drs. T. Oomens; tel. 020-599 4698; e-mail: firstname.lastname@example.org
Study nurse: F.R. Bosman; tel. 020-599 3440; e-mail: email@example.com