The Pacing vs No Pacing Study - PNP Study

Phase 4

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: percutaneous balloon aortic valvuloplasty

• Registration Number: NCT02498639
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-13
• Last Update Submitted: 2015-07-13
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAV without pacing	percutaneous balloon aortic valvuloplasty	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.
BAV with pacing	percutaneous balloon aortic valvuloplasty	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.

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).	Post-procedural, on average 30 minutes after the procedure.	Echocardiography performed 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

Name	Time	Method
Acute myocardial infarction	30-day
Major bleeding (BARC ≥3)	30-day
New cardiovascular hospital admission	30-day
Ictus incidence	30-day
Haemodynamic trans-aortic gradient reduction ≥ 50%	Just after last balloon inflation, on average 3 minutes after BAV
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.
Haemodynamic trans-aortic gradient reduction from 30 to 49%	Just after last balloon inflation, on average 3 minutes after BAV
Overall mortality	30-day
Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).	Post-procedural, on average 30 minutes after the procedure.	Echocardiography performed 30 minutes after the procedure.
Trans-aortic gradient reduction from 30 to 49%	Post-procedural, on average 30 minutes after the procedure.	Echocardiography performed 30 minutes after the procedure.
Cardiovascular mortality	30-day
Acute severe aortic insufficiency	Just after last balloon inflation, on average few seconds after BAV

Trial Locations

Locations (1)

Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy