Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique (MIDAS - ULM)

University of Ulm

Status: Completed

Conditions: PM Implantation After TAVR

Treatments: Procedure: TAVR

Study type: Observational

Funder types: Other

Identifiers

NCT04734392

01/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

300 participants in 2 patient groups

Cohort A

Description:

Historical cohort 2019 + 2020

Cohort B

Description:

Prospective study cohort 2020 + 2021 (TAVR implantation according new IFU)

Treatment:

Procedure: TAVR