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

• Sponsor: Michele De Bonis (Other)
• Overall Status: Completed
• CT.gov ID: NCT05836532
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Actual Duration (Days): 10
• Patients Per Site Per Month: 334.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Degenerative Mitral Valve Disease; Mitral Regurgitation	Procedure: Central edge-to-edge

Study Design

• Study Type: Observational
• Actual Enrollment: 110 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
• Actual Study Start Date: Oct 5, 2019
• Actual Primary Completion Date: Oct 15, 2019
• Actual Study Completion Date: Oct 15, 2019

Outcome Measures

Primary Outcome Measures

1. MR 2+ or more recurrency [through study completion, a minimum of 2 years]

Secondary Outcome Measures

1. Reintervention [through study completion, a minimum of 2 years]

Eligibility Criteria

Criteria

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

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...)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele - Cardiac Surgery Department	Milan		Italy	20132

Sponsors and Collaborators

• Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michele De Bonis, Chief od Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele
• ClinicalTrials.gov Identifier: NCT05836532
• Other Study ID Numbers: LORD-P2_DMR
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• 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
• Additional relevant MeSH terms: Mitral Valve Insufficiency; Prolapse

Study Results

No Results Posted as of May 1, 2023