MIDAS - ULM: Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique

Sponsor
University of Ulm (Other)
Overall Status
Recruiting
CT.gov ID
NCT04734392
Collaborator
(none)
300
1
26.9
11.1

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
  • Procedure: TAVR

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

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Cohort A

Historical cohort 2019 + 2020

Cohort B

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

Procedure: TAVR
TAVR implantation in cusp overlay technique

Outcome Measures

Primary Outcome Measures

  1. Pacemaker implantation rate [Day 5 after TAVR]

    Primary endpoint

Secondary Outcome Measures

  1. Extent of paravalvular leak [Day 5 after TAVR]

    Secondary endpoint

  2. Number of patients alive [30 days]

    Secondary endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients referred to TAVR procedure due to severe aortic stenosis
Exclusion Criteria:
  • PM-implantation before TAVR

  • Valve-in-valve procedures

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Dr. Dominik Buckert, PD Dr. Dominik Buckert, MD, University of Ulm
ClinicalTrials.gov Identifier:
NCT04734392
Other Study ID Numbers:
  • 01/2021
First Posted:
Feb 2, 2021
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 2, 2021