Interventional Structural Registry - LuEbeck | NCT06977139

Studies
Interventional Structural Registry - LuEbeck

NCT06977139

Sponsor

Prof. Dr. med. Ingo Eitel

Status

Recruiting

Last Update Posted

May 18, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Structural Heart Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
21-330	Registry Identifier	INSTYLE

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2021Actual

Primary Completion Date

Jan 1, 2030Estimated

Completion Date

Jan 1, 2035Estimated

First Submitted Date

May 8, 2025

First Submission Date that Met QC Criteria

May 8, 2025

First Posted Date

May 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2025

Last Update Posted Date

May 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Structural heart disease

Exclusion Criteria:

Patients without consent/information
Age ≤ 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ingo Eitel, Prof. Dr.	Contact	+49 451 500 44501		cvro@uksh.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Schleswig-Holstein	Recruiting	Lübeck	Schleswig-Holstein		Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided