Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy

NCT06702527 | Not Yet Recruiting DMC

• 1 other identifier: The MOTOR Registry
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.

Conditions

Mitral Regurgitation Functional; Heart Failure; M-TEER

Keywords

Mitral Regurgitation; Heart Failure; M-TEER; Optimizing GDMT; Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)

  Number of 6- and 12-months heart failure (HF) hospitalizations post M-TEER procedure compared to 12- and 6-months historical HF hospitalization prior the index procedure

  6 and 12 months

Secondary Outcomes (2)

• New York Heart Association (NYHA) class

  6 months

• 6-minute walk test

  6 months

Study Arms (1)

M-TEER patients

Patients with optimized guideline-directed medical therapy (GDMT) undergoing mitral transcatheter edge-to-edge repair (M-TEER, using the PASCAL system) for severe functional mitral regurgitation.

Procedure: Mitral transcatheter edge-to-edge repair

Interventions

Mitral transcatheter edge-to-edge repair PROCEDURE

Mitral transcatheter edge-to-edge repair with the PASCAL system

Also known as: M-TEER

M-TEER patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe functional and mixed-type mitral regurgitation with optimized GMDT undergoing M-TEER (using the PASCAL system)

You may qualify if:

• mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision
• Severe functional and mixed-type mitral regurgitation with LV-EF \< 50%
• Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system
• Provision of written informed consent

You may not qualify if:

• Degenerative mitral regurgitation
• Emergency procedure
• Re-do or concomitant (mitral/tricuspid) procedures
• Patients on maximum dose GDMT
• Atrial functional mitral regurgitation (FMR)
• Coronary revascularisation within the last 3 months
• Pregnant woman

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (1)

Cellitinnen Hospital St. Vinzenz

Cologne, North Rhine-Westphalia, 50733, Germany

Location

Related Publications (5)

• Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.

  PMID: 36876756 BACKGROUND

• Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. doi: 10.1016/j.jacc.2018.04.070.

  PMID: 30025570 BACKGROUND

• Savarese G, Bodegard J, Norhammar A, Sartipy P, Thuresson M, Cowie MR, Fonarow GC, Vaduganathan M, Coats AJS. Heart failure drug titration, discontinuation, mortality and heart failure hospitalization risk: a multinational observational study (US, UK and Sweden). Eur J Heart Fail. 2021 Sep;23(9):1499-1511. doi: 10.1002/ejhf.2271. Epub 2021 Jun 28.

  PMID: 34132001 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

• Adamo M, Tomasoni D, Stolz L, Stocker TJ, Pancaldi E, Koell B, Karam N, Besler C, Giannini C, Sampaio F, Praz F, Ruf T, Pechmajou L, Neuss M, Iliadis C, Baldus S, Butter C, Kalbacher D, Lurz P, Melica B, Petronio AS, von Bardeleben RS, Windecker S, Butler J, Fonarow GC, Hausleiter J, Metra M. Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration. JACC Cardiovasc Interv. 2023 Apr 24;16(8):896-905. doi: 10.1016/j.jcin.2023.01.362. Epub 2023 Mar 22.

  PMID: 37100553 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Officials

• Jan-Malte Sinning, Prof.

  Cellitinnen Hospital St. Vinzenz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia M Lüske, PhD

CONTACT

+49 4471 8503324; claudia.lueske@ippmed.de

Marie F Zielinski

CONTACT

+49 4471 8503326; marie.zielinski@ippmed.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)