An observational study in PM Implantation After TAVR, sponsored by University of Ulm. Completed at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University of Ulm · Observational
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.
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.
University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Historical cohort 2019 + 2020
Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU)
Procedure: TAVR
TAVR implantation in cusp overlay technique
Pacemaker implantation rate
Primary endpoint
Time frame: Day 5 after TAVR
Extent of paravalvular leak
Secondary endpoint
Time frame: Day 5 after TAVR
Number of patients alive
Secondary endpoint
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Ulm