The Pacing vs No Pacing Study - PNP Study

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Unknown; Phase 4

Conditions: Aortic Valve Stenosis

Treatments: Procedure: percutaneous balloon aortic valvuloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02498639

CE41/2015/O/Sper

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

BAV without pacing

Active Comparator group

Description:

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.

Treatment:

Procedure: percutaneous balloon aortic valvuloplasty

BAV with pacing

Active Comparator group

Description:

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.

Treatment:

Procedure: percutaneous balloon aortic valvuloplasty