Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
NCT ID: NCT04734392
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2020-01-01
2023-11-28
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cohort A
Historical cohort 2019 + 2020
No interventions assigned to this group
Cohort B
Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU)
TAVR
TAVR implantation in cusp overlay technique
Interventions
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TAVR
TAVR implantation in cusp overlay technique
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Valve-in-valve procedures
65 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Dr. Dominik Buckert
PD Dr. Dominik Buckert, MD
Locations
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Ulm University
Ulm, , Germany
Countries
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Other Identifiers
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01/2021
Identifier Type: -
Identifier Source: org_study_id