Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04734392 |
| Other study ID # |
01/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
November 28, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University of Ulm |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 0.05, beta
0.80).
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.
