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

November 28, 2023 updated by: Dr. Dominik Buckert, University of Ulm
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • Ulm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pacemaker implantation rate
Time Frame: Day 5 after TAVR
Primary endpoint
Day 5 after TAVR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of paravalvular leak
Time Frame: Day 5 after TAVR
Secondary endpoint
Day 5 after TAVR
Number of patients alive
Time Frame: 30 days
Secondary endpoint
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 01/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PM Implantation After TAVR

Clinical Trials on TAVR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe