Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03715894
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2018-10-02
Brief Title:
Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry
Sponsor:
Institut für Pharmakologie und Präventive Medizin
Organization:
Institut für Pharmakologie und Präventive Medizin
Study Overview
Official Title:
Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve
Status:
COMPLETED
Status Verified Date:
2023-06
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:
Conduct-pro
Brief Summary:
There are procedure related risk factors for permanent pacemaker implantation PPI that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI
Prospective multicenter European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve Additional assessment of calcification using a CT data core lab Statistical analysis of the dataset obtained with respect to the objectives of the registry
Prospective multicenter European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve Additional assessment of calcification using a CT data core lab Statistical analysis of the dataset obtained with respect to the objectives of the registry
Detailed Description:
Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure
While a number of registries have documented the rates of PPI with different valves much less evidence has been provided for
1 patient based characteristics eg RBBB etc affecting the likelihood of PPI and for
2 procedural variables eg implantation hieght valve size etc that should be considered to perform as safe and minimal invasive procedure as possible
Prior Research To date there are 8 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV
These studies suggest that the need for pacemaker implantation in single centers ranges between 144 and 204 based on patient numbers between 131 and 335 patients
These analyses resulted in the identification of pre-existing conduction disturbance aortic valve calcification heavily calcified LVOT RBBB persistent complete heart blocks prolonged QRS duration or short membranous septum as patient related factors associated with PPI during Edwards SAPIEN 3 THV TAVI Similarly procedural variables such as implantation height oversizing as procedure related variables are associated with PPI after TAVI
The literature regarding procedure related variables associated with permanent pacemaker implantation in patients receiving an Edwards SAPIEN 3 valve shows multivariable analyses with slightly different views to the requested procedural variables
Tarantini et al suggest a higher valve implantation ventricular ratio 6040 at qualitative assessment or depth 8mm at qualitative assessment A similar outcome was reported by De Torres-Alba et al Due to the longer stent of the SAPIEN 3 they suggest an even higher implantation intending a shorter extension of the stent into the LVOT by increasing the percentage of the stent in the aorta to 70 Schwerg et al compare the PPI rate in low implantation with high implantation independently from the patients pre-existing conduction disturbances and suggest to minimize the risk of PPI by choosing a higher implantation technique with the central marker 2 mm or more over the annular plane
Furthermore Mauri et al encourage to choose a implantation height of 255 Implantation height was expressed as the percentage of the ventricular part of the stent frame in relation to the overall stent frame length
Another procedural factor is found to be aortic annulus oversizing ratios which are known to prevent paravalvular leakage Leber et al show the rate of post-procedural permanent pacemakers tended to be lower in patients with 15 oversizing compared to those with 25 oversizing for Edwards Sapien XT Using SAPIEN 3 valves Husser et al show a higher PPI rate in patients with out of range oversizing
Gonska et al conclude that neither implantation height nor oversizing has an effect on PPI rate
On the other hand the need for pre-dilatation by balloon valvuloplasty and post-implant dilatation have not been identified as potential contributing factors for PPI as it is believed the impact of the dilatation on the conduction tissue is transient and short lived
Nevertheless pre- and post-dilatation should be further considered and analysed
Hypothetically also the following procedural parameters which have not been investigated in detail so far could be risks for PPIs Stiff guidewire use or a no touch policy and should be considered in this research
Limitations of prior research Current evidence though is limited by patient numbers versus event rates with a max of 62 PPI considered in any of the available datasets resulting in a limited power in multivariable analyses the single center design of these ventures the lack of a consistent definition of variables potentially associated with PPI and the unexplained differences in the number and type of variables identified
Aims This registry aims to assess procedural variables and to verify risk factors in a prospective multicenter registry
To identify predictors of PPI patients with a high risk for PPI will be preferably included to increase the power compared to pre-existing database analyses from single centres The target is to identify general procedural predictors and to verify risk factors of PPI post TAVI with the Edwards SAPIEN 3 valve which when identified and avoided will reduce the need of PPI in the future
While a number of registries have documented the rates of PPI with different valves much less evidence has been provided for
1 patient based characteristics eg RBBB etc affecting the likelihood of PPI and for
2 procedural variables eg implantation hieght valve size etc that should be considered to perform as safe and minimal invasive procedure as possible
Prior Research To date there are 8 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV
These studies suggest that the need for pacemaker implantation in single centers ranges between 144 and 204 based on patient numbers between 131 and 335 patients
These analyses resulted in the identification of pre-existing conduction disturbance aortic valve calcification heavily calcified LVOT RBBB persistent complete heart blocks prolonged QRS duration or short membranous septum as patient related factors associated with PPI during Edwards SAPIEN 3 THV TAVI Similarly procedural variables such as implantation height oversizing as procedure related variables are associated with PPI after TAVI
The literature regarding procedure related variables associated with permanent pacemaker implantation in patients receiving an Edwards SAPIEN 3 valve shows multivariable analyses with slightly different views to the requested procedural variables
Tarantini et al suggest a higher valve implantation ventricular ratio 6040 at qualitative assessment or depth 8mm at qualitative assessment A similar outcome was reported by De Torres-Alba et al Due to the longer stent of the SAPIEN 3 they suggest an even higher implantation intending a shorter extension of the stent into the LVOT by increasing the percentage of the stent in the aorta to 70 Schwerg et al compare the PPI rate in low implantation with high implantation independently from the patients pre-existing conduction disturbances and suggest to minimize the risk of PPI by choosing a higher implantation technique with the central marker 2 mm or more over the annular plane
Furthermore Mauri et al encourage to choose a implantation height of 255 Implantation height was expressed as the percentage of the ventricular part of the stent frame in relation to the overall stent frame length
Another procedural factor is found to be aortic annulus oversizing ratios which are known to prevent paravalvular leakage Leber et al show the rate of post-procedural permanent pacemakers tended to be lower in patients with 15 oversizing compared to those with 25 oversizing for Edwards Sapien XT Using SAPIEN 3 valves Husser et al show a higher PPI rate in patients with out of range oversizing
Gonska et al conclude that neither implantation height nor oversizing has an effect on PPI rate
On the other hand the need for pre-dilatation by balloon valvuloplasty and post-implant dilatation have not been identified as potential contributing factors for PPI as it is believed the impact of the dilatation on the conduction tissue is transient and short lived
Nevertheless pre- and post-dilatation should be further considered and analysed
Hypothetically also the following procedural parameters which have not been investigated in detail so far could be risks for PPIs Stiff guidewire use or a no touch policy and should be considered in this research
Limitations of prior research Current evidence though is limited by patient numbers versus event rates with a max of 62 PPI considered in any of the available datasets resulting in a limited power in multivariable analyses the single center design of these ventures the lack of a consistent definition of variables potentially associated with PPI and the unexplained differences in the number and type of variables identified
Aims This registry aims to assess procedural variables and to verify risk factors in a prospective multicenter registry
To identify predictors of PPI patients with a high risk for PPI will be preferably included to increase the power compared to pre-existing database analyses from single centres The target is to identify general procedural predictors and to verify risk factors of PPI post TAVI with the Edwards SAPIEN 3 valve which when identified and avoided will reduce the need of PPI in the future
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