Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done through a dedicated computer program.
The aim is to compare, in terms of procedural success and safety, the procedure of percutaneous balloon aortic valvuloplasty (BAV) without rapid ventricular pacing with the same procedure carried out with the aid of rapid ventricular pacing. It is a pilot study with the objective to enroll 100 consecutive patients matching inclusion and exclusion criteria who are randomized 1:1 in two arms: in the first patients undergo procedure of BAV without rapid pacing, in the second BAV with rapid ventricular pacing able to help in balloon stabilization during inflations. Efficacy will be studied analysing changes in transvalvular gradient from baseline to post-BAV. Safety outcomes will be collected both at discharge and at 30-day. Other procedural data will be object of direct comparison.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Percutaneous BAV is performed according to the standard retrograde technique. The measurement of the trans-aortic gradient is given by two catheters placed one in the left ventricle, the other in ascending aorta. An extra stiff wire is placed in the left ventricular cavity. A balloon (size fitting the valve annulus) is inserted over the wire and a series of three inflations is performed at nominal pressure. The procedure terminates in case of: 1. Reduction of the mean aortic gradient ≥50%. 2. Aortic pressure drop during the inflations, indicative of valve orifice sealing. 3. Intraprocedural complication. 4. Poor compliance of the patient. If none is met, the balloon is changed with a bigger one and a new series of three inflations performed. Aortic gradient is finally recorded.
Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
RECRUITINGEfficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).
Echocardiography performed 30 minutes after the procedure.
Time frame: Post-procedural, on average 30 minutes after the procedure.
Composite safety endpoint: death, myocardial infarction, stroke, acute aortic valve insufficiency, major bleeding (BARC classification ≥3)
Time frame: 30-day
Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).
Echocardiography performed 30 minutes after the procedure.
Time frame: Post-procedural, on average 30 minutes after the procedure.
Trans-aortic gradient reduction from 30 to 49%
Echocardiography performed 30 minutes after the procedure.
Time frame: Post-procedural, on average 30 minutes after the procedure.
Haemodynamic trans-aortic gradient reduction ≥ 50%
Time frame: Just after last balloon inflation, on average 3 minutes after BAV
Haemodynamic trans-aortic gradient reduction from 30 to 49%
Time frame: Just after last balloon inflation, on average 3 minutes after BAV
Overall mortality
Time frame: 30-day
Cardiovascular mortality
Time frame: 30-day
Ictus incidence
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Time frame: 30-day
Acute myocardial infarction
Time frame: 30-day
Acute severe aortic insufficiency
Time frame: Just after last balloon inflation, on average few seconds after BAV
Major bleeding (BARC ≥3)
Time frame: 30-day
New cardiovascular hospital admission
Time frame: 30-day
Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure
Time frame: Post-procedural, on average 30 minutes after the procedure.