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Completed

NCT Number: NCT03470155

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

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.

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Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Left Ventricular Systolic Dysfunction Mitral Valve Prolapse Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum Leipzig, Leipzig, Saxony, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitral valve repair

Procedure

operative reconstruction

Primary outcomes

  1. recurrent mitral valve insufficiency > grade 2

    Time frame: 2 years

    see above

Secondary outcomes

  1. MACCE

    Time frame: 1 year

    major adverse cardiovascular and cerebrovascular events

  2. re-intervention at mitral valve

    Time frame: 2 years

    see above

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

    Time frame: 2 years

    see above

  4. cardiovascular mortality

    Time frame: 2 years

    see above

  5. re-hospitalisation due to heart failure

    Time frame: 2 years

    see above

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Registry information

Official study title

Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion

Acronym: REFORM-MR

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Mar 19, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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