The Pacing vs No Pacing Study - PNP Study (PNP)

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: percutaneous balloon aortic valvuloplasty

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Francesco Saia, MD; Phone Number: 00390512144475; Email: francescosaia@hotmail.com
    • Contact: Gianni Dall'Ara, MD; Phone Number: 00390512144475; Email: dallara.gianni@gmail.com
    • Principal Investigator: Antonio Marzocchi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BAV without pacing; 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; 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.
Active Comparator: BAV with pacing; 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; 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Time Frame
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).	Just after last balloon inflation, on average 3 minutes after BAV
Acute kidney injury	at hospital discharge, on average 3 days after BAV
Hospitalization duration	at hospital discharge, on average 3 days after BAV

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Antonio Marzocchi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: outcome; balloon aortic valvuloplasty; rapid ventricular pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CE41/2015/O/Sper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No