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

Mitral Valve Insufficiency Clinical Trial

— REFORM-MR  

Official title:

Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470155
• Other study ID #: REFORM-MR
• Status: Completed
• Start date: June 5, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 31, 2023
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Systolic Dysfunction
• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Prolapse
• Systolic Murmurs
• Ventricular Dysfunction, Left

Intervention

Procedure:
• mitral valve repair
operative reconstruction

Locations

Country	Name	City	State
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Charité - Klinik für kardiovaskuläre Chirurgie	Berlin
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE	Hamburg
Germany	Herzzentrum Leipzig	Leipzig	Sachsen
Germany	Deutsches Herzzentrum München	München

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent mitral valve insufficiency > grade 2	see above	2 years
Secondary	MACCE	major adverse cardiovascular and cerebrovascular events	1 year
Secondary	re-intervention at mitral valve	see above	2 years
Secondary	device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure	see above	2 years
Secondary	cardiovascular mortality	see above	2 years
Secondary	re-hospitalisation due to heart failure	see above	2 years