Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique

Completed

• Conditions: PM Implantation After TAVR
• Interventions: Procedure: TAVR

• Registration Number: NCT04734392
• Lead Sponsor: University of Ulm

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.

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-02-02
• Primary Completion: 2023-06-30
• Status Verified: 2023-11
• Study Completion: 2023-11-28
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• All patients referred to TAVR procedure due to severe aortic stenosis

Exclusion Criteria

• PM-implantation before TAVR
• Valve-in-valve procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	TAVR	Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU)

Primary Outcome Measures

Name	Time	Method
Pacemaker implantation rate	Day 5 after TAVR	Primary endpoint

Secondary Outcome Measures

Name	Time	Method
Extent of paravalvular leak	Day 5 after TAVR	Secondary endpoint
Number of patients alive	30 days	Secondary endpoint

Trial Locations

Locations (1)

Ulm University; 🇩🇪 Ulm, Germany