Clinical trial NCT02498639: The Pacing vs No Pacing Study - PNP Study
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: balloon aortic valvuloplasty
rapid ventricular pacing
outcome
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).
timeFrame: Post-procedural, on average 30 minutes after the procedure.
measure: Composite safety endpoint: death, myocardial infarction, stroke, acute aortic valve insufficiency, major bleeding (BARC classification ≥3)
timeFrame: 30-day
Secondary outcomes:
measure: Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).
timeFrame: Post-procedural, on average 30 minutes after the procedure.
measure: Trans-aortic gradient reduction from 30 to 49%
timeFrame: Post-procedural, on average 30 minutes after the procedure.
measure: Haemodynamic trans-aortic gradient reduction ≥ 50%
timeFrame: Just after last balloon inflation, on average 3 minutes after BAV
measure: Haemodynamic trans-aortic gradient reduction from 30 to 49%
timeFrame: Just after last balloon inflation, on average 3 minutes after BAV
measure: Overall mortality
timeFrame: 30-day
measure: Cardiovascular mortality
timeFrame: 30-day
measure: Ictus incidence
timeFrame: 30-day
measure: Acute myocardial infarction
timeFrame: 30-day
measure: Acute severe aortic insufficiency
timeFrame: Just after last balloon inflation, on average few seconds after BAV
measure: Major bleeding (BARC ≥3)
timeFrame: 30-day
measure: New cardiovascular hospital admission
timeFrame: 30-day
measure: Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure
timeFrame: Post-procedural, on average 30 minutes after the procedure.
Other outcomes:
measure: Compare change in transvalvular gradient pre and post BAV measured between the left ventricle and aorta (LV-Ao) vs gradient measured between the left ventricle and femoral artery (LV-periphery).
timeFrame: Just after last balloon inflation, on average 3 minutes after BAV
measure: Acute kidney injury
timeFrame: at hospital discharge, on average 3 days after BAV
measure: Hospitalization duration
timeFrame: at hospital discharge, on average 3 days after BAV
Locations:
city: Bologna
country: Italy
facility: Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Antonio Marzocchi, MD
role: PRINCIPAL_INVESTIGATOR
References: