Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04734392
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-01-26
Brief Title:
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Status:
COMPLETED
Status Verified Date:
2023-11
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:
MIDAS - ULM
Brief Summary:
Hypothesis of the study is that a modified and improved implantation protocol regarding membranous septum length and implantation depth will decrease the need for permanent pacemaker stimulation follow TAVR-procedures
Detailed Description:
Project objectives or hypothesis Hypothesis of the study is that a modified and improved implantation protocol regarding membranous septum length and implantation depth will decrease the need for permanent pacemaker stimulation following TAVR-procedures
Patient profile and sample size The study cohort will comprise of patients referred to transcatheter aortic valve replacement Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany TAVR will be performed according to a modified implantation technique regarding membranous septum length Pacemaker rates will be analyzed and compared to a historical control Taking into account a contemporary pacemaker rate of 15 a reduction to 7 will require a sample size of 239 patients per group to achieve statistically significance Chi-squared test alpha 005 beta 080
Regarding the prospective cohort interims analysis will be performed after each 10 TAVR procedures In case a signal towards worse outcomes with the modified implantation technique will be observed the institutional safety and endpoint adjudication committee will stop further execution of the study
Patient profile and sample size The study cohort will comprise of patients referred to transcatheter aortic valve replacement Patients will be prospectively and consecutively screened and enrolled at a tertiary high-volume center in Germany TAVR will be performed according to a modified implantation technique regarding membranous septum length Pacemaker rates will be analyzed and compared to a historical control Taking into account a contemporary pacemaker rate of 15 a reduction to 7 will require a sample size of 239 patients per group to achieve statistically significance Chi-squared test alpha 005 beta 080
Regarding the prospective cohort interims analysis will be performed after each 10 TAVR procedures In case a signal towards worse outcomes with the modified implantation technique will be observed the institutional safety and endpoint adjudication committee will stop further execution of the study
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