Trials / Completed
CompletedNCT04734392
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- University of Ulm · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TAVR | TAVR implantation in cusp overlay technique |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2023-06-30
- Completion
- 2023-11-28
- First posted
- 2021-02-02
- Last updated
- 2023-11-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04734392. Inclusion in this directory is not an endorsement.