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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03470155
Recruitment Status : Active, not recruiting
First Posted : March 19, 2018
Last Update Posted : December 21, 2021
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

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.

Condition or disease Intervention/treatment
Mitral Valve Insufficiency Left Ventricular Systolic Dysfunction Mitral Valve Prolapse 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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. recurrent mitral valve insufficiency > grade 2 [ Time Frame: 2 years ]
    see above

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03470155

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Herzzentrum Leipzig
Leipzig, Sachsen, Germany, 04289
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
Charité - Klinik für kardiovaskuläre Chirurgie
Berlin, Germany, 10117
Universitätsklinikum Frankfurt
Frankfurt, Germany
Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE
Hamburg, Germany, 20246
Deutsches Herzzentrum München
München, Germany, 80636
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
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Principal Investigator: Evaldas Girdauskas, MD Universitäres Herzzentrum Hamburg am UKE
Additional Information:

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Responsible Party: Institut für Pharmakologie und Präventive Medizin Identifier: NCT03470155    
Other Study ID Numbers: REFORM-MR
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD will be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
annuloplasty mitral valve
reduced LV function
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Mitral Valve Prolapse
Systolic Murmurs
Pathological Conditions, Anatomical
Heart Murmurs
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Heart Valve Prolapse