Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02498639
Status:
UNKNOWN
Last Update Posted:
2015-07-15
First Post:
2015-07-10
Brief Title:
The Pacing vs No Pacing Study - PNP Study
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNP
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 11 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
It is a pilot study with the objective to enroll 100 consecutive patients matching inclusion and exclusion criteria who are randomized 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None