Aortic Valve Stenosis Clinical Trial
Official title:
Comparison of Safety and Efficacy of Percutaneous Balloon Aortic Valvuloplasty Performed With or Without Rapid Ventricular Pacing - The Pacing vs No Pacing Study (PNP Study)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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