Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function (REFORM-MR)

Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Insufficiency; Mitral Valve Prolapse; Left Ventricular Systolic Dysfunction
• Intervention / Treatment: Procedure: mitral valve repair

Detailed Description

Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb).

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka
  • Berlin, Germany, 10117
    • Charité - Klinik für kardiovaskuläre Chirurgie
  • Frankfurt, Germany
    • Universitatsklinikum Frankfurt
  • Hamburg, Germany, 20246
    • Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE
  • München, Germany, 80636
    • Deutsches Herzzentrum München
  • Sachsen
    • Leipzig, Sachsen, Germany, 04289
      • Herzzentrum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; operative reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrent mitral valve insufficiency > grade 2	see above	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	major adverse cardiovascular and cerebrovascular events	1 year
re-intervention at mitral valve	see above	2 years
device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure	see above	2 years
cardiovascular mortality	see above	2 years
re-hospitalisation due to heart failure	see above	2 years

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Evaldas Girdauskas, MD, Universitäres Herzzentrum Hamburg am UKE

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2018
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: annuloplasty mitral valve; reduced LV function
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Murmurs; Heart Valve Prolapse; Ventricular Dysfunction; Mitral Valve Insufficiency; Prolapse; Systolic Murmurs; Mitral Valve Prolapse; Ventricular Dysfunction, Left
• Other Study ID Numbers: REFORM-MR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no IPD will be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No