Brief Title
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)
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).
Secondary Outcome
Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).
Condition
Aortic Valve Stenosis
Intervention
percutaneous balloon aortic valvuloplasty
Study Arms / Comparison Groups
BAV without pacing
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
April 2015
Completion Date
January 2016
Primary Completion Date
December 2015
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.
Gender
All
Ages
70 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Antonio Marzocchi, MD, 00390512144475, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT02498639
Organization ID
CE41/2015/O/Sper
Responsible Party
Principal Investigator
Study Sponsor
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Study Sponsor
Antonio Marzocchi, MD, Principal Investigator, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Verification Date
July 2015