Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function

NCT03470155 | Completed

• 1 other identifier: REFORM-MR
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 6

Brief Summary

Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.

Conditions

Mitral Valve Insufficiency; Left Ventricular Systolic Dysfunction; Mitral Valve Prolapse

Keywords

annuloplasty mitral valve; reduced LV function

Outcome Measures

Primary Outcomes (1)

• recurrent mitral valve insufficiency > grade 2

  see above

  2 years

Secondary Outcomes (5)

• MACCE

  1 year

• re-intervention at mitral valve

  2 years

• device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure

  2 years

• cardiovascular mortality

  2 years

• re-hospitalisation due to heart failure

  2 years

Study Arms (1)

functional mitral insufficiency op

Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair)

Procedure: mitral valve repair

Interventions

mitral valve repair PROCEDURE

operative reconstruction

functional mitral insufficiency op

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 presenting at participating hospitals with mitral valve dysfunction type III b who give written consent to participate in the registry

You may qualify if:

• functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) - effective regurgitation orifice area \> 20 mm2 / regurgitant volume \> 30 ml/beat
• left ventricular ejection fraction \<= 50% and /or left ventricular end-diastolic diameter \>= 60 mm
• tenting of the proximal and / or anterior mitral leaflets

You may not qualify if:

• prolaps of leaflets (type II mitral regurgitation)
• combination intervention with aortic valve repair or replacement
• re-operation at mitral valve

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (6)

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Charité - Klinik für kardiovaskuläre Chirurgie

Berlin, 10117, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE

Hamburg, 20246, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

Related Publications (2)

• Pausch J, Harmel E, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Walther T, Krane M, Vitanova K, Borger MA, Eden M, Hachaturyan V, Bramlage P, Falk V, Girdauskas E. Subannular repair in secondary mitral regurgitation with restricted leaflet motion during systole. Heart. 2023 Aug 24;109(18):1394-1400. doi: 10.1136/heartjnl-2022-322239.

  PMID: 37376817 DERIVED

• Girdauskas E, Pausch J, Reichenspurner H, Kempfert J, Kuntze T, Owais T, Holubec T, Krane M, Vitanova K, Borger M, Eden M, Hachaturyan V, Bramlage P, Falk V. Subannular repair for functional mitral regurgitation with reduced systolic ventricle function: rationale and design of REFORM-MR registry. J Cardiothorac Surg. 2022 Dec 30;17(1):343. doi: 10.1186/s13019-022-02045-9.

  PMID: 36581901 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency; Ventricular Dysfunction, Left; Mitral Valve Prolapse

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Valve Prolapse

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Evaldas Girdauskas, MD

  Universitäres Herzzentrum Hamburg am UKE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: June 5, 2018
• Primary Completion: July 15, 2020
• Study Completion: July 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)