Valvular Heart DiseaseNCT03488732
Valvular Heart Disease Registry
An observational study of Valvular Heart Disease, run by Technical University of Munich at 1 site in Germany.
Trial summary
Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Transcatheter valvular repair or replacement
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2015to 1 Jan 2030
- How long will I take part?
- 10 Years
- 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
- Adult, Older adult
Study population: Patients undergoing transcatheter valvular interventions
Who may be able to join
- Severe valvular defect planned for valvular intervention
Who cannot join
- No informed consent
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
Klinik für Innere Medizin I
München
Jakob Ledwoch, Dr, +4941402350, jakob.ledwoch@mri.tum.de
About this study
Official title: Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions
Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.
- Conditions
- Valvular Heart Disease
- Being tested
- Transcatheter valvular repair or replacement
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter valvular repair or replacementDevice
Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergonig transcatheter valvular interventions | Not described Receives: Device: Transcatheter valvular repair or replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 10 years
Secondary outcomes (3)
Cardiovascular mortality
Measured: 10 years
NYHA status
Measured: 10 years
Grade of mitral regurgitation
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Apr 2015
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488732
- Sponsor's protocol ID
- V1
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valvular Heart Disease Registry - Observational Study of Percutaneous Valvular Interventions
- ClinicalTrials.gov ID
- NCT03488732
- Acronym / sponsor ID
- V1
- Conditions
- Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 5 Apr 2018 (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.
Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergonig transcatheter valvular interventions | – | Device: Transcatheter valvular repair or replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transcatheter valvular interventions
Key inclusion criteria (1 listed)
- Severe valvular defect planned for valvular intervention
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter valvular repair or replacementTranscatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis) | Device | Patients undergonig transcatheter valvular interventions |
Primary outcome
All-cause mortality
Time frame: 10 years
3 secondary outcomes
Cardiovascular mortality
Time frame: 10 years
NYHA status
Time frame: 10 years
Grade of mitral regurgitation
Time frame: 10 years
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 10 Apr 2019.
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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 Valvular Heart Disease, run by Technical University of Munich 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 1 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 10 Apr 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 10 years). 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 10 Apr 2019.