The Pacing vs No Pacing Study - PNP Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: percutaneous balloon aortic valvuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of severe symptomatic aortic valve stenosis. no immediate indication to aortic valve replacement (AVR). indication to balloon aortic valvuloplasty (BAV). written expression of informed consent. Exclusion Criteria: clinical presentation in cardiogenic shock at the time of BAV. clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BAV without pacing<br>Patients undergo percutaneous balloon aortic valvuloplasty (BAV) without previous insertion of a temporary pacemaker lead in the right ventricle. Stabilization of the balloon during inflation is done without rapid pacing. | Procedure: percutaneous balloon aortic valvuloplasty<br>* 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: Reduction of the mean aortic gradient ≥50%. Aortic pressure drop during the inflations, indicative of valve orifice sealing. Intraprocedural complication. 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.<br>|
| Active Comparator: BAV with pacing<br>Patients undergo percutaneous balloon aortic valvuloplasty (BAV) after previous insertion of a temporary pacemaker lead in the right ventricle. Stabilization of the balloon during inflation is done under rapid pacing. | Procedure: percutaneous balloon aortic valvuloplasty<br>* 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: Reduction of the mean aortic gradient ≥50%. Aortic pressure drop during the inflations, indicative of valve orifice sealing. Intraprocedural complication. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy 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. | 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) |  | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment). | Echocardiography performed 30 minutes after the procedure. | Post-procedural, on average 30 minutes after the procedure. | 
| Trans-aortic gradient reduction from 30 to 49% | Echocardiography performed 30 minutes after the procedure. | Post-procedural, on average 30 minutes after the procedure. | 
| Haemodynamic trans-aortic gradient reduction ≥ 50% |  | Just after last balloon inflation, on average 3 minutes after BAV | 
| Haemodynamic trans-aortic gradient reduction from 30 to 49% |  | Just after last balloon inflation, on average 3 minutes after BAV | 
| Overall mortality |  | 30-day | 
| Cardiovascular mortality |  | 30-day | 
| Ictus incidence |  | 30-day | 
| Acute myocardial infarction |  | 30-day | 
| Acute severe aortic insufficiency |  | Just after last balloon inflation, on average few seconds after BAV | 
| Major bleeding (BARC ≥3) |  | 30-day | 
| New cardiovascular hospital admission |  | 30-day | 
| Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure |  | Post-procedural, on average 30 minutes after the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balloon aortic valvuloplasty, rapid ventricular pacing, outcome