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CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Sponsor: Universitätsklinikum Hamburg-Eppendorf

NCT ID: NCT04688190

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 121 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This registry study, run by Universitätsklinikum Hamburg-Eppendorf, collects information on people with mitral regurgitation (a leaky heart valve) and related mitral valve problems, including mitral annular calcification (calcium build-up around the valve). It looks at different ways of treating the leaky valve. Not stated — ask the trial team for more details on the study's main aims.

Who can take part

  • You have a mitral valve leak that doctors consider clinically significant (serious enough to matter for your health).
  • You were checked (screened) for a procedure called TMVI (a way of replacing the mitral valve without open-heart surgery).
  • You had heart ultrasound scans (echocardiography) at the start, and after TMVI, E2E repair, or surgery.
  • You were followed up for at least 30 days.

Who may not be able to

  • People under 18 years old.

What taking part involves

  • • The registry records information about treatments for a leaky mitral valve, including TMVI (transcatheter mitral valve implantation — placing a new valve through a tube without open-heart surgery), E2E (edge-to-edge repair — a procedure that clips parts of the valve together), and heart surgery.
  • • Heart ultrasound scans (echocardiography) are used to check the valve at the start and after treatment.
  • • Not stated — ask the trial team about any other tests or procedures involved.

Time commitment: At least 30 days of follow-up after treatment, with heart ultrasound scans at the start and after treatment — other details not stated; ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2020-11-01
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for mitral regurgitation
  • • Clinical study - 1,000 participants
  • • This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with mitral regurgitation

Where?

  • • London - Royal Brompton Hospital
  • • London - St Thomas' Hospital - London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice. Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.

Mitral RegurgitationMitral Valve DiseaseMitral Annular Calcification

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓clinically significant mitral insufficiency
  • ✓patient underwent screening for TMVI
  • ✓echocardiography data at baseline (and after TMVI, E2E and surgery)
  • ✓follow-up of at least 30 days

Who cannot take part

  • ✗\- age under 18 years
See the full criteria
Inclusion Criteria: * clinically significant mitral insufficiency * patient underwent screening for TMVI * echocardiography data at baseline (and after TMVI, E2E and surgery) * follow-up of at least 30 days Exclusion Criteria: \- age under 18 years

Where Is This Study? (2 UK sites)

Royal Brompton Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

St Thomas' Hospital - London

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

How to Get in Touch

Sebastian Ludwig, MD

Sponsor contact

CONTACT

+494074100 se.ludwig@uke.de

Lena Strotmann, MD

Sponsor contact

CONTACT

+4074100 L.Strotmann@uke.de
Data sourced from ClinicalTrials.gov · Last verified: 2026-05