Structural Heart DiseaseINSTYLENCT06977139
Interventional Structural Registry - LuEbeck
An observational study of Structural Heart Disease, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural Heart Disease
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2021to 1 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Structural heart disease
Who cannot join
- Patients without consent/information
- Age ≤ 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein
Ingo Eitel, Prof. Dr., +49 451 500 44501, ingo.eitel@uksh.de
About this study
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
- Conditions
- Structural Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint
Combined endpoint of NYHA classification, re-hospitalization, death, repeat procedure, heart transplantation, LVAD implantation (the order is not relevant) by day 30.
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start11 Sep 2021
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Ingo Eitel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977139
- Sponsor's protocol ID
- 21-330
- Other IDs
- 21-330
- Acronym
- INSTYLE
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Structural Registry - LuEbeck
- ClinicalTrials.gov ID
- NCT06977139
- Acronym / sponsor ID
- INSTYLE / 21-330
- Conditions
- Structural Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Ingo EitelUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Structural heart disease
Key exclusion criteria (2 listed)
- Patients without consent/information
- Age ≤ 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined endpoint
Time frame: 30days
Combined endpoint of NYHA classification, re-hospitalization, death, repeat procedure, heart transplantation, LVAD implantation (the order is not relevant) by day 30.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Structural Heart Disease, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingo Eitel, Prof. Dr. (+49 451 500 44501, cvro@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.