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

NCT05836532 | Completed

• 1 other identifier: LORD-P2_DMR
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Degenerative Mitral Valve Disease; Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• MR 2+ or more recurrency

  through study completion, a minimum of 2 years

Secondary Outcomes (1)

• Reintervention

  through study completion, a minimum of 2 years

Interventions

Central edge-to-edge PROCEDURE

Suture of free margins of the mitral leaflets in central position to restore coaptation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with degenerative MR, due to P2 prolapse, who underwent surgery with central edge to edge

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief od Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: May 1, 2023
• Study Start: October 5, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)