Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499428
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Ventricular Pacing Rate in Follow-up of Patients Treated With Definitive PM Implantation Post TAVI
Sponsor:
IRCCS Ospedale Galeazzi-SantAmbrogio
Organization:
IRCCS Ospedale Galeazzi-SantAmbrogio
Study Overview
Official Title:
Tasso di Stimolazione Ventricolare Nel Follow-up Dei Pazienti Sottoposti ad Impianto di PM Post TAVIFattori Predittivi ed Evoluzione Clinica
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
P-P-P-TAVI
Brief Summary:
The goal of this observational study is to learn about the effective ventricular pacing rate in follow-up of patients who underwent a pacemaker PM implantation after transcatheter aortic valve implantation TAVI
Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates
Secondly the study want investigate possible conduction recovery in follow up of patients and possible predictive factors of different ventricular pacing rates
Detailed Description:
Aortic stenosis represents the most common valve defect in developed countries Percutaneous transcatheter aortic valve implantation TAVI is now a first-line therapy for aortic stenosis
The development of conduction blocks remains one of the most frequent complications of TAVI 3-26 requiring the implantation of a permanent pacemaker PM
The damage caused to the conduction system during TAVI is the consequence of the anchoring of the prosthesis to the membranous septum
There are several clinical procedural and anatomical variables that correlate with a higher risk of permanent PM implantation post-TAVI including age pre-existence of BBDX development of BBSX post TAVI use of self-valves -expanding and implantation depth of the bioprosthesis
Some anatomical variables obtained from the CT study appear to correlate with a greater risk of damage to the conduction system post-TAVI
Recent studies have proven the importance of an accurate measurement of the length of the membranous septum to design the depth of the bioprosthesis implant while minimizing the risk of damage to the conduction system
The damage suffered by the conduction system following the anchoring of the bioprosthesis is largely inflammatory and can as such be unpredictable in its evolution and regress over time
Recent data from the literature suggest that right ventricular stimulation by PM may in the long term worsen the prognosis of patients undergoing TAVI and be associated with a higher rate of mortality from all causes and hospitalizations for decompensation particularly when the percentage of PM stimulation is 40
Furthermore post-TAVI permanent PM implantation correlates with increased intensive care and hospitalization times as well as healthcare costs
Literature data regarding the evolution of post-TAVI conduction defects are still relatively lacking and studies regarding the pacing percentage and its impact in post-TAVR patients are limited especially in the long term and based on small populations
According to a recent meta-analysis approximately half of the patients are not pacemaker dependent 1 year after implantation furthermore the presence of pre-existing right bundle branch block and the use of self-expanding valves appear to be associated with a doubled risk of developing pacemaker dependence
The possibility and time of recovery of the conduction system post TAVI and consequently the need for ventricular pacing could also depend on some anatomical variables including the length of the membranous septum and the presence of sub-valvular calcifications
The development of conduction blocks remains one of the most frequent complications of TAVI 3-26 requiring the implantation of a permanent pacemaker PM
The damage caused to the conduction system during TAVI is the consequence of the anchoring of the prosthesis to the membranous septum
There are several clinical procedural and anatomical variables that correlate with a higher risk of permanent PM implantation post-TAVI including age pre-existence of BBDX development of BBSX post TAVI use of self-valves -expanding and implantation depth of the bioprosthesis
Some anatomical variables obtained from the CT study appear to correlate with a greater risk of damage to the conduction system post-TAVI
Recent studies have proven the importance of an accurate measurement of the length of the membranous septum to design the depth of the bioprosthesis implant while minimizing the risk of damage to the conduction system
The damage suffered by the conduction system following the anchoring of the bioprosthesis is largely inflammatory and can as such be unpredictable in its evolution and regress over time
Recent data from the literature suggest that right ventricular stimulation by PM may in the long term worsen the prognosis of patients undergoing TAVI and be associated with a higher rate of mortality from all causes and hospitalizations for decompensation particularly when the percentage of PM stimulation is 40
Furthermore post-TAVI permanent PM implantation correlates with increased intensive care and hospitalization times as well as healthcare costs
Literature data regarding the evolution of post-TAVI conduction defects are still relatively lacking and studies regarding the pacing percentage and its impact in post-TAVR patients are limited especially in the long term and based on small populations
According to a recent meta-analysis approximately half of the patients are not pacemaker dependent 1 year after implantation furthermore the presence of pre-existing right bundle branch block and the use of self-expanding valves appear to be associated with a doubled risk of developing pacemaker dependence
The possibility and time of recovery of the conduction system post TAVI and consequently the need for ventricular pacing could also depend on some anatomical variables including the length of the membranous septum and the presence of sub-valvular calcifications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None