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

• Sponsor: Institut für Pharmakologie und Präventive Medizin (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03470155
• Collaborator: (none)
• Enrollment: 200
• Locations: 6
• Anticipated Duration (Months): 52.3
• Patients Per Site: 33.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase
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).

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
• Actual Study Start Date: Jun 5, 2018
• Anticipated Primary Completion Date: Oct 15, 2022
• Anticipated Study Completion Date: Oct 15, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. recurrent mitral valve insufficiency > grade 2 [2 years]

   see above

Secondary Outcome Measures

1. MACCE [1 year]

   major adverse cardiovascular and cerebrovascular events

2. re-intervention at mitral valve [2 years]

   see above

3. device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure [2 years]

   see above

4. cardiovascular mortality [2 years]

   see above

5. re-hospitalisation due to heart failure [2 years]

   see above

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herzzentrum Leipzig	Leipzig	Sachsen	Germany	04289
2	Zentralklinik Bad Berka	Bad Berka		Germany	99437
3	Charité - Klinik für kardiovaskuläre Chirurgie	Berlin		Germany	10117
4	Universitätsklinikum Frankfurt	Frankfurt		Germany
5	Klinik und Poliklinik für Herz- und Gefäßchirurgie am UHZ am UKE	Hamburg		Germany	20246
6	Deutsches Herzzentrum München	München		Germany	80636

Sponsors and Collaborators

• Institut für Pharmakologie und Präventive Medizin

Investigators

• Principal Investigator: Evaldas Girdauskas, MD, Universitäres Herzzentrum Hamburg am UKE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut für Pharmakologie und Präventive Medizin
• ClinicalTrials.gov Identifier: NCT03470155
• Other Study ID Numbers: REFORM-MR
• First Posted: Mar 19, 2018
• Last Update Posted: Dec 21, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Mitral Valve Insufficiency; Mitral Valve Prolapse; Prolapse; Systolic Murmurs

Study Results

No Results Posted as of Dec 21, 2021