Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:

Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836532
• Other study ID #: LORD-P2_DMR
• Status: Completed
• Start date: October 5, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery.

Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed.

The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mitral regurgitation with degenerative etiology

• Mitral pathology exclusively dependent on P2

• Surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique.

Exclusion Criteria:

• Other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)

Related Conditions & MeSH terms

• Degenerative Mitral Valve Disease
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Prolapse

Intervention

Procedure:
• Central edge-to-edge
Suture of free margins of the mitral leaflets in central position to restore coaptation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele - Cardiac Surgery Department	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MR 2+ or more recurrency		through study completion, a minimum of 2 years
Secondary	Reintervention		through study completion, a minimum of 2 years