Atrial Functional Mitral RegurgitationNCT06911099
Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)
An observational study of Atrial Functional Mitral Regurgitation and Mitral Insufficiency, run by University Hospital of Cologne at 22 sites in 6 countries.
Trial summary
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Functional Mitral Regurgitation, Mitral Insufficiency
- How many people
- 1,000 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 1 Jan 2010to 31 Dec 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: This study aimes to include all patients with clinically significant mitral regurgitation of the atrial functional mitral regurgitation subtype, irrespective of the subsequent therapy.
Who may be able to join
- functional mitral regurgitation
- left ventricular ejection fraction ≥50%
Who cannot join
- age under 18 years
- known regional wall movement disorders
Trial locations and contacts
22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 6 countries
Germany10 sites, 10 recruiting
- Recruiting
HDZ Bad Oeynhausen
Bad Oeynhausen
Volker Rudolph, MD, +495731971276, vrudolph@hdz-nrw.de
Muhammed Gerçek, MD, +495731971276, mugercek@hdz-nrw.de
- Recruiting
Heart Center Bonn
Bonn
Georg Nickenig, MD, +4922828715217, Georg.Nickenig@ukbonn.de
Marcel Weber, MD, +4922828715299, Marcel.Weber@ukbonn.de
- Recruiting
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Philipp von Stein, MD, 646-321-8145, philipp.von-stein@uk-koeln.de
Christos Iliadis, MD
- Recruiting
University Hospital of Düsseldorf
Düsseldorf
Maximilian Spieker, MD, +492118118801, Maximilian.Spieker@med.uni-duesseldorf.de
- Recruiting
University Heart and Vascular Center Hamburg
Hamburg
Sebastian Ludwig, MD, se.ludwig@uke.de
- Recruiting
University Hospital Schleswig-Holstein
Kiel
Felix Kreidel, MD, +4943150022801, Felix.Kreidel@uksh.de
- Recruiting
Heart Center Leipzig at University of Leipzig
Leipzig
Tobias Kister, MD, +49341865252536, Tobias.Kister@helios-gesundheit.de
- Recruiting
Heart Center of the University Medical Center Mainz
Mainz
Ralph Stephan von Bardeleben, MD, +496131178786, stephan.von_bardeleben@unimedizin-mainz.de
Tobias Ruf, MD, tobias.ruf@unimedizin-mainz.de
- Recruiting
LMU Klinikum
Munich, Bavaria, 81377
Jörg Hausleiter, Prof. Dr., +4989440072361, Joerg.Hausleiter@med.uni-muenchen.de
Lukas Stolz, MD, +49 1525 488 9915, Lukas.Stolz@med.uni-muenchen.de
- Recruiting
University Heart Center Ulm
Ulm
Mirjam Kessler, MD, +4973150045001, Mirjam.Kessler@uniklinik-ulm.de
Matthias Gröger, MD, +4973150045001, matthias.groeger@uniklinik-ulm.de
Spain5 sites, 5 recruiting
- Recruiting
Hospital Clinic of Barcelona
Barcelona
Xavier Freixa, MD, +34932275400 ext. 2035, freixa@clinic.cat
- Recruiting
Reina Sofia University Hospital
Córdoba
Manuel Pan Álvarez-Ossorio, MD, +34676999144, manuelpanalvarez@gmail.com
- Recruiting
University Hospital of León
León
Tomás Benito-González, MD, +34987237400, tomasbenito@outlook.com
- Recruiting
Asturias Central University Hospital
Oviedo
Isaac Pascual Calleja, MD, +34917242370, pascualcisaac@uniovi.es
- Recruiting
University Hospital Alvaro Cunqueiro
Vigo
Rodrigo Estevez-Loureiro, MD, +34986811111, roiestevez@hotmail.com
Italy3 sites, 3 recruiting
- Recruiting
University of Brescia
Brescia
Marianna Adamo, MD, PhD, +393897834503, mariannaadamo@hotmail.com
- Recruiting
San Raffaele University Hospital
Milan
Francesco Maisano, MD, +39226437109, francesco.maisano@hsr.it
Guido Ascione, MD, gascione@crf.org
- Recruiting
University of Pisa
Pisa
Cristina Giannini, MD, +3950996975, cristinagianninimd@gmail.com
France2 sites, 2 recruiting
- Recruiting
Bordeaux University Hospital
Bordeaux
Thomas Modine, MD, PhD, +33557656969, thomasmodine@gmail.com
Guillaume Bonnet, MD, gbonnet@crf.org
- Recruiting
University Hospital Center of Nantes
Nantes
Patrice Guérin, MD, +33240998383, Patrice.Guerin@univ-nantes.fr
Robin Le Ruz, MD, robin.leruz@chu-nantes.fr
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York
Azeem Latib, MD, (718) 920-4212, mlatib@montefiore.org
Andrea Scotti, MD, a.scotti@hotmail.com
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto
Neil Fam, MD, 416-864-5939, Neil.Fam@unityhealth.to
About this study
Official title: Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.
- Keywords
- atrial functional mitral regurgitation, AFMR, atrial secondary mitral regurgitation, ASMR, mitral valve transcatheter edge-to-edge repair, M-TEER
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER) | Patients who underwent mitral valve transcatheter edge-to-edge repair. All devices may be included. | |
| Guideline Directed Medical Therapy | Patients who underwent conservative management with guideline directed medical therapy. | |
| Transcatheter Mitral Valve Replacement (TMVR) | Patients who underwent transcatheter mitral valve replacement. All devices may be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality and heart-failure related rehospitalitzation
Measured: 12 months
Secondary outcomes (7)
Residual Mitral Regurgitation ≤1+
Rate of patients achieving residual mitral regurgitation ≤1+ measured by transthoracic echocardiography. Assessment of mitral regurgitation severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease.
Measured: 12 months
All-cause mortality
Measured: 12 months
Cardiovascular mortality
Measured: 12 months
Heart failure related rehospitalization
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.
Measured: 12 months
Unplanned mitral valve intervention
Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation.
Measured: 12 months
New York Heart Association (NYHA) class III or IV
Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient), with the minimum of I (no symptoms) and the maximum of IV (dyspnea at rest), with higher values indicating worse functional capacity.
Measured: 12 months
6 Minute Walking Distance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Functional Mitral RegurgitationStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp von Stein, University Hospital of Cologne
- Investigators
- Christos Iliadis, MD, Principal investigator, Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911099
- Sponsor's protocol ID
- 24-1121
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT06911099
- Acronym / sponsor ID
- 24-1121
- Keywords
- atrial functional mitral regurgitation, AFMR, atrial secondary mitral regurgitation, ASMR, mitral valve transcatheter edge-to-edge repair, M-TEER
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 4 Apr 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.
This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER) | – | –Patients who underwent mitral valve transcatheter edge-to-edge repair. All devices may be included. |
| Guideline Directed Medical Therapy | – | –Patients who underwent conservative management with guideline directed medical therapy. |
| Transcatheter Mitral Valve Replacement (TMVR) | – | –Patients who underwent transcatheter mitral valve replacement. All devices may be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aimes to include all patients with clinically significant mitral regurgitation of the atrial functional mitral regurgitation subtype, irrespective of the subsequent therapy.
Key inclusion criteria (2 listed)
- functional mitral regurgitation
- left ventricular ejection fraction ≥50%
Key exclusion criteria (2 listed)
- age under 18 years
- known regional wall movement disorders
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
Composite of all-cause mortality and heart-failure related rehospitalitzation
Time frame: 12 months
7 secondary outcomes
Residual Mitral Regurgitation ≤1+
Time frame: 12 months
All-cause mortality
Time frame: 12 months
Cardiovascular mortality
Time frame: 12 months
Heart failure related rehospitalization
Time frame: 12 months
Unplanned mitral valve intervention
Time frame: 12 months
New York Heart Association (NYHA) class III or IV
Time frame: 12 months
6 Minute Walking Distance
Time frame: 12 months
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 6 Apr 2025.
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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.
Christos Iliadis, MD principal investigator
Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Functional Mitral Regurgitation and Mitral Insufficiency, run by University Hospital of Cologne at 22 sites in 6 countries.
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 2 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Spain, Italy, France, United States and 1 more country. 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 Philipp von Stein, MD (646-321-8145, philipp.von-stein@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality and heart-failure related rehospitalitzation (time frame: 12 months). 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 6 Apr 2025.