NCT06977139

Brief Summary

The aim of the registry is to investigate the effect of catheter-assisted procedures in the context of structural heart disease on clinical morbidity and mortality. Furthermore, the long-term prognosis of patients after a catheter-based procedure is to be evaluated. In particular, the following parameters will be documented and the following questions discussed:

  • Underlying and concomitant diseases of these patients
  • Evaluation of the methods in relation to the respective disease
  • Safety - acute and long-term
  • Effectiveness - periprocedural, hospital and long-term course
  • Concomitant therapies

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress35%
Sep 2021Jan 2035

Study Start

First participant enrolled

September 11, 2021

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

8.3 years

First QC Date

May 8, 2025

Last Update Submit

May 8, 2025

Conditions

Structural Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint

    Combined endpoint of NYHA classification, re-hospitalization, death, repeat procedure, heart transplantation, LVAD implantation (the order is not relevant) by day 30.

    30days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients for who the indication for a catheter-based heart valve replacement or closure system was set due to a structural heart disease can be included.

You may qualify if:

  • Structural heart disease

You may not qualify if:

  • Patients without consent/information
  • Age ≤ 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

RECRUITING

Central Study Contacts

Ingo Eitel, Prof. Dr.

CONTACT

+49 451 500 44501cvro@uksh.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 18, 2025

Study Start

September 11, 2021

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2035

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations

DE(1)