MIDAS - ULM: Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Cohort A Historical cohort 2019 + 2020 |
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Cohort B Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU) |
Procedure: TAVR
TAVR implantation in cusp overlay technique
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Outcome Measures
Primary Outcome Measures
- Pacemaker implantation rate [Day 5 after TAVR]
Primary endpoint
Secondary Outcome Measures
- Extent of paravalvular leak [Day 5 after TAVR]
Secondary endpoint
- Number of patients alive [30 days]
Secondary endpoint
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients referred to TAVR procedure due to severe aortic stenosis
Exclusion Criteria:
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PM-implantation before TAVR
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Valve-in-valve procedures
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ulm University | Ulm | Germany | 89081 |
Sponsors and Collaborators
- University of Ulm
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01/2021