Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Insufficiency; Atrial Functional Mitral Regurgitation

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Philipp von Stein, MD; Phone Number: 646-321-8145; Email: philipp.von-stein@uk-koeln.de
• Study Contact Backup: Name: Christos Iliadis, MD; Phone Number: +49-221-478-32401; Email: christos.iliadis@uk-koeln.de

Study Locations

• Canada
  • Toronto, Canada
    • Recruiting
    • St. Michael's Hospital
    • Contact: Neil Fam, MD; Phone Number: 416-864-5939; Email: Neil.Fam@unityhealth.to
• France
  • Bordeaux, France
    • Recruiting
    • Bordeaux University Hospital
    • Contact: Thomas Modine, MD, PhD; Phone Number: +33557656969; Email: thomasmodine@gmail.com
    • Contact: Guillaume Bonnet, MD; Email: gbonnet@crf.org
  • Nantes, France
    • Recruiting
    • University Hospital Center of Nantes
    • Contact: Patrice Guérin, MD; Phone Number: +33240998383; Email: Patrice.Guerin@univ-nantes.fr
    • Contact: Robin Le Ruz, MD; Email: robin.leruz@chu-nantes.fr
• Germany
  • Bad Oeynhausen, Germany
    • Recruiting
    • HDZ Bad Oeynhausen
    • Contact: Volker Rudolph, MD; Phone Number: +495731971276; Email: vrudolph@hdz-nrw.de
    • Contact: Muhammed Gerçek, MD; Phone Number: +495731971276; Email: mugercek@hdz-nrw.de
  • Bonn, Germany
    • Recruiting
    • Heart Center Bonn
    • Contact: Georg Nickenig, MD; Phone Number: +4922828715217; Email: georg.nickenig@ukbonn.de
    • Contact: Marcel Weber, MD; Phone Number: +4922828715299; Email: Marcel.Weber@ukbonn.de
  • Düsseldorf, Germany
    • Recruiting
    • University Hospital of Düsseldorf
    • Contact: Maximilian Spieker, MD; Phone Number: +492118118801; Email: Maximilian.Spieker@med.uni-duesseldorf.de
  • Hamburg, Germany
    • Recruiting
    • University Heart and Vascular Center Hamburg
    • Contact: Sebastian Ludwig, MD; Email: se.ludwig@uke.de
  • Kiel, Germany
    • Recruiting
    • University Hospital Schleswig-Holstein
    • Contact: Felix Kreidel, MD; Phone Number: +4943150022801; Email: Felix.Kreidel@uksh.de
  • Leipzig, Germany
    • Recruiting
    • Heart Center Leipzig at University of Leipzig
    • Contact: Tobias Kister, MD; Phone Number: +49341865252536; Email: Tobias.Kister@helios-gesundheit.de
  • Mainz, Germany
    • Recruiting
    • Heart Center of the University Medical Center Mainz
    • Contact: Ralph Stephan von Bardeleben, MD; Phone Number: +496131178786; Email: stephan.von_bardeleben@unimedizin-mainz.de
    • Contact: Tobias Ruf, MD; Email: tobias.ruf@unimedizin-mainz.de
  • Ulm, Germany
    • Recruiting
    • University Heart Center Ulm
    • Contact: Mirjam Kessler, MD; Phone Number: +4973150045001; Email: Mirjam.Kessler@uniklinik-ulm.de
    • Contact: Matthias Gröger, MD; Phone Number: +4973150045001; Email: matthias.groeger@uniklinik-ulm.de
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • LMU Klinikum
      • Contact: Jörg Hausleiter, Prof. Dr.; Phone Number: +4989440072361; Email: Joerg.Hausleiter@med.uni-muenchen.de
      • Contact: Lukas Stolz, MD; Phone Number: +49 1525 488 9915; Email: Lukas.Stolz@med.uni-muenchen.de
  • NRW
    • Cologne, NRW, Germany, 50937
      • Recruiting
      • University Hospital Cologne
      • Contact: Philipp von Stein, MD; Phone Number: 646-321-8145; Email: philipp.von-stein@uk-koeln.de
      • Contact: Christos Iliadis, MD
• Italy
  • Brescia, Italy
    • Recruiting
    • University of Brescia
    • Contact: Marianna Adamo, MD, PhD; Phone Number: +393897834503; Email: mariannaadamo@hotmail.com
  • Milan, Italy
    • Recruiting
    • San Raffaele University Hospital
    • Contact: Francesco Maisano, MD; Phone Number: +39226437109; Email: francesco.maisano@hsr.it
    • Contact: Guido Ascione, MD; Email: gascione@crf.org
  • Pisa, Italy
    • Recruiting
    • University of Pisa
    • Contact: Cristina Giannini, MD; Phone Number: +3950996975; Email: cristinagianninimd@gmail.com
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: Xavier Freixa, MD; Phone Number: 2035 +34932275400; Email: freixa@clinic.cat
  • Cordoba, Spain
    • Recruiting
    • Reina Sofia University Hospital
    • Contact: Manuel Pan Álvarez-Ossorio, MD; Phone Number: +34676999144; Email: manuelpanalvarez@gmail.com
  • Leon, Spain
    • Recruiting
    • University Hospital of León
    • Contact: Tomás Benito-González, MD; Phone Number: +34987237400; Email: tomasbenito@outlook.com
  • Oviedo, Spain
    • Recruiting
    • Asturias Central University Hospital
    • Contact: Isaac Pascual Calleja, MD; Phone Number: +34917242370; Email: pascualcisaac@uniovi.es
  • Vigo, Spain
    • Recruiting
    • University Hospital Alvaro Cunqueiro
    • Contact: Rodrigo Estevez-Loureiro, MD; Phone Number: +34986811111; Email: roiestevez@hotmail.com
• United States
  • New York
    • Bronx, New York, United States
      • Recruiting
      • Montefiore Medical Center
      • Contact: Azeem Latib, MD; Phone Number: (718) 920-4212; Email: mlatib@montefiore.org
      • Contact: Andrea Scotti, MD; Email: a.scotti@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• functional mitral regurgitation
• left ventricular ejection fraction ≥50%

Exclusion Criteria:

• age under 18 years
• known regional wall movement disorders

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of all-cause mortality and heart-failure related rehospitalitzation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		12 months
Cardiovascular mortality		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.	12 months
Unplanned mitral valve intervention	Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation.	12 months
6 Minute Walking Distance		12 months
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.	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.	12 months

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Investigators: Principal Investigator: Christos Iliadis, MD, Heart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: M-TEER; ASMR; atrial functional mitral regurgitation; AFMR; atrial secondary mitral regurgitation; mitral valve transcatheter edge-to-edge repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 24-1121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No