The Pacing vs No Pacing Study - PNP Study

Aortic Valve Stenosis Clinical Trial

— PNP  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02498639
• Other study ID #: CE41/2015/O/Sper
• Status: Recruiting
• Phase: Phase 4
• First received: July 10, 2015
• Last updated: July 13, 2015
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2015
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: Antonio Marzocchi, MD
• Phone: 00390512144475
• Email: antonio.marzocchi[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.

Locations

Country	Name	City	State
Italy	Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Acute kidney injury		at hospital discharge, on average 3 days after BAV	Yes
Other	Hospitalization duration		at hospital discharge, on average 3 days after BAV	No
Primary	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.	No
Primary	Composite safety endpoint: death, myocardial infarction, stroke, acute aortic valve insufficiency, major bleeding (BARC classification =3)		30-day	Yes
Secondary	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.	No
Secondary	Trans-aortic gradient reduction from 30 to 49%	Echocardiography performed 30 minutes after the procedure.	Post-procedural, on average 30 minutes after the procedure.	No
Secondary	Haemodynamic trans-aortic gradient reduction = 50%		Just after last balloon inflation, on average 3 minutes after BAV	No
Secondary	Haemodynamic trans-aortic gradient reduction from 30 to 49%		Just after last balloon inflation, on average 3 minutes after BAV	No
Secondary	Overall mortality		30-day	Yes
Secondary	Cardiovascular mortality		30-day	Yes
Secondary	Ictus incidence		30-day	Yes
Secondary	Acute myocardial infarction		30-day	Yes
Secondary	Acute severe aortic insufficiency		Just after last balloon inflation, on average few seconds after BAV	Yes
Secondary	Major bleeding (BARC =3)		30-day	Yes
Secondary	New cardiovascular hospital admission		30-day	Yes
Secondary	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.	No