NCT04734392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.5 years

First QC Date

January 26, 2021

Last Update Submit

November 28, 2023

Conditions

PM Implantation After TAVR

Outcome Measures

Primary Outcomes (1)

  • Pacemaker implantation rate

    Primary endpoint

    Day 5 after TAVR

Secondary Outcomes (2)

  • Extent of paravalvular leak

    Day 5 after TAVR

  • Number of patients alive

    30 days

Study Arms (2)

Cohort A

Historical cohort 2019 + 2020

Cohort B

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

Procedure: TAVR

Interventions

TAVRPROCEDURE

TAVR implantation in cusp overlay technique

Cohort B

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulm University

Ulm, 89081, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Dominik Buckert, MD

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 2, 2021

Study Start

January 1, 2020

Primary Completion

June 30, 2023

Study Completion

November 28, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(1)